Compression device

ABSTRACT

A compression device for applying compression to a body part of a user. The compression device has a sleeve with two lateral side regions and a central region in-between. The central region of the sleeve comprises a main material having elasticity in at least a transverse direction. A maximum elongation in the transverse direction is from 5% up to and including 30% under a load of 10 N per cm width and a difference quotient of tension in the transverse direction from 20% elongation to 25% elongation equal to or greater that 0.6 N per cm width per percent elongation. The device further includes a releasable closure system configured and arranged relative to the sleeve, such that, in use, upon closure of the closure system the sleeve is restrained and tightened about the body part of the user.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a national stage filing under 35 U.S.C. 371 ofPCT/US2014/031220, filed Mar. 19, 2014, which claims priority to GreatBritain Application No. 1305545.4, filed Mar. 27, 2013, the disclosuresof which are incorporated by reference in their entirety herein.

FIELD

The present disclosure relates to compression devices. In particular,the present disclosure relates to compression devices for applyingcompression to a body part (e.g. a limb, torso, neck or head) of a userfor the use in the treatment and/or management of oedema and othervenous and lymphatic disorders, more particularly venous leg ulcers andlymphoedema of a limb.

BACKGROUND

Compression therapy is generally prescribed to support an insufficientvenous or lymphatic system in returning blood or lymph to the heart.Accordingly, compression is generally considered to be the standardtreatment for use in the treatment of oedema and other venous andlymphatic disorders e.g. of the lower limbs venous leg ulcers and otherclinical conditions, such as lymphoedema. The positive effects ofcompression therapy on venous lymph return, as well as on the healing ofchronic venous (leg) ulcers, are well documented in the medicalliterature.

Compression bandages are one of the common compression systems used forcompression therapy. The use of such compression bandages generallyinvolves the application of a multilayer compression bandage. Oneconcept behind a number of such multi-layer bandaging systems is the useof a combination of different types of bandage layers in order to applypressure in layers (giving an accumulation of pressure) and to providesustained compression together with rigidity. Commercially availablecompression bandages include bandages marketed under the tradedesignations “3M COBAN 2 LAYER COMPRESSION SYSTEM” and “3M COBAN 2 LITECOMPRESSION SYSTEM”. Typically to assure proper and effectivecompression bandaging, it is normally necessary for a medicalprofessional to apply the bandages. In consideration of the fact in thestart of treatment of lymphoedema or in other compression therapieswhere oedema is present, compression bandages typically need to bereplaced frequently due to changes in pressure (e.g. reduction ofpressure) and/or in uniformity of pressure of the compression bandage asthe amount of oedema is reduced during compression therapy, the need ofhaving a medical professional change and reapply the compression bandageto ensure the desired pressure profile for continuing compressiontreatment can be limiting.

Compression stockings are often applied by users themselves. However,they often do not provide the desired therapeutic compressive pressureor are alternatively very hard to put on. Moreover, compressionstockings need to be quite elastic showing high stretch so that one canpull them on and off. Such stockings retain this high stretch whilebeing worn on the limb, and accordingly their effectiveness in terms ofcompression therapy is rather limited.

Other compression systems have been marketed and/or proposed. Forexample, U.S. Pat. No. 6,152,893 (Pigg et al; SMITH& NEPHEW) discloses acompression device for applying a predetermined compression to a limbcomprising a pliable non-extensible sheet to be wrapped around a limb,where said sheet is provided with a plurality of cooperating first andsecond fastening parts each along opposing edges of the sheet, therebyto secure the device to the limb, wherein said first fastening part isprovided with a plurality of first and second related indicia thatvisually indicate the relative movement of said first fastening partrelative to said second fastening part between the application of zerotension as indicated by said first indicia and the application of apredetermined optimal degree of tension as indicated by said secondindicia on fastening said first and second parts to provide compression.WO 01/72250 (Bennet et al; NEOPRESS) discloses an elastic compressionsupport for supporting a wound dressing around the lower leg and foot ofa patient, the support comprising a panel and a line of fastenings fordrawing together two long edges of the panel where the fasteningscomprise mutually aligned pairs of tapes secured to or tabs integralwith the panel along its edges arranged so that drawing the tape or tabsapart in mutually opposite directions causes the panel to be tightenedin compression around the limb, wherein the panel is formed from threepieces including a central piece, that lies at the back of the calf andunder the foot, made of a long-stretch microperforated neoprene and twoside pieces, that form the two long edges of panel and lie along theshin and the front of the leg, made of short-stretch microperforatedneoprene. WO 97/46181 (Shaw et al; CIRCAID MEDICAL PRODUCTS) discloses atherapeutic compression garment including a plurality of pairs of bodyor limb encircle bands integrally connected to a central wrap aroundregion and extending outwardly in opposite direction from the both sidesof the central region to encompass the body part. WO 2011/066237(Lipshaw et al; CIRCAID MEDICAL PRODUCTS) discloses a therapeuticcompression garment, including: a body portion; and a spine portion,wherein the spine portion is releasably attached along a spine curveonto the body portion such that the spine portion is positionable atdifferent locations on the body portion and wherein there are bandsextending from either the body portion and/or the spine portion, thebands further securing the body and spine portions together when thebody and spine portions are wrapped around a body limb. A correspondinggarment is marketed by CIRCAID under the trade designation JUXTA-CURESwhich is formed from the body and spine portion between attached over aspine curve and includes four limb encircling bands (two per side, eachincluding hook & loop type fasteners) integrally connected to both thebody portion and the spine portion, the bands being located in staggeredpositions along the two opposite sides garment and extending outwardlyin opposite directions from the both sides of the garment to encompassthe body part. U.S. 2005/0209545 (Farrow et al; FARROW MEDICAL)discloses an apparatus for applying pressure to a body part comprisingmultiple interconnectable bands of compressible or non-compressiblematerial and that the bands can be overlapped and connected to eithervia an spine or connective means lengthwise centrally in each band. Acorresponding system is marketed by FARROW under the trade designationFARROWWRAP.

SUMMARY

While the aforementioned other compression systems may be, in part,easier to put on, it has been found that these systems still suffer anumber of disadvantages, e.g. not providing desirable therapeuticcompressive pressure and/or showing gaps, e.g. between bands or otheropen spaces (leading to undesirable area(s) of non-compression within aregion undergoing compression and thus a unfavorable potential for fluidaccumulation in said area(s)) and/or wrinkling and/or having narrowregions of overlap between regions of non-overlap (the latter twoleading to non-uniform pressures, in particular areas of exceedinglyhigh pressure).

Accordingly, there is an ongoing need or desire for a compression devicethat provides desirably effective compression therapy and is at the sametime easy to put on and use, ideally without necessarily having amedical professional put it and/or change it each and every time.

We have found that it is particularly advantageous to provide a sleevefor substantially covering a portion of the body part (e.g. a limb,torso, neck, head) of a user where the sleeve is provided with closuresystem, such that in use upon closure of the closure system the sleeveis restrained and tightened about the body part of the user to providecompression (e.g. by drawing together the lateral side edges of sleeve),where the main material of the sleeve serving to provide compression hasparticular, select material properties. In this regard it has been foundto be particular favorable to use a material having elasticity in thetransverse direction of the sleeve together a maximum elongation from 5%to 30% under a load of 10 N per cm width in said transverse direction inconjunction with a difference quotient of tension in said transversedirection from 20% elongation to 25% elongation of at least 0.6 N per cmwidth per percent elongation.

Accordingly, there is disclosed a compression device for applyingcompression to a body part of a user comprising a sleeve forsubstantially covering a portion of the body part of a user, wherein thesleeve has an outer surface, an inner surface, an upper edge, a loweredge and two lateral side edges, wherein in the transverse directionfrom the first lateral side edge to the second lateral side edge thesleeve comprises a first lateral side region, a central region and asecond lateral side region, and wherein at least the central region ofthe sleeve comprises a material (referred to in following as “mainmaterial”) having elasticity in at least the transverse direction of thesleeve, a maximum elongation in said transverse direction from 5% up toand including 30% under a load of 10 N per cm width and a differencequotient of tension in transverse direction from 20% elongation to 25%elongation equal to or greater that 0.6 N per cm width per percentelongation; the device further comprising a releasable closure system,said closure system being configured and arranged relative to thesleeve, such that, in use, upon closure of the closure system the sleeveis restrained and tightened about the body part of the user.

For the sake of clarity, it is to be appreciated that after applicationof a compression device onto a body part (e.g. a limb, torso, neck orhead) of a user, the transverse direction of the sleeve will also be acircumferential direction. In accordance with ASTM D4848-98 (2012) andBS EN 14704-1:2005 elasticity is that property of a material by virtueof which it tends to recover its original size and shape immediatelyafter removal of the force causing deformation. Elongation as well asrecovered elongation may be determined in accordance with the standardBS EN 14704-1:2005 “Determination of the elasticity of fabrics, —Part 1:Strip tests”: Method A, Knitted Fabrics e.g. as described in detailbelow in the experimental section under the sub-section entitled “TestMethodology for Elongation and Recovered Elongation”. Tension may bedetermined in accordance with the BS EN 14704-1:2005 “Determination ofthe elasticity of fabrics, —Part 1: Strip tests”: Method A, KnittedFabrics e.g. as described in detail below in the experimental sectionunder the sub-section entitled “Test Methodology for Tension”

By employing in the sleeve a main material with very short stretchcharacteristics in conjunction with a relatively high (in other wordssteep) difference quotient of tension from 20% elongation to 25%elongation in said transverse direction, one can provide a compressiondevice that provides desirably high standing pressures as a result of ahigh resistance to stretch, once applied. This has been found particularadvantageous for effective compression therapy. Moreover, in oneembodiment it is desirable to apply a compression device with stretchingbetween about 10% to about 20% using a selected compression materialhaving a steep difference quotient from 20% elongation to 25% elongationso that once applied the compression material resists any furtherstretching which in turns allow the attainment of high standingpressures.

In one embodiment, the difference quotient of tension in transversedirection from 20% elongation to 25% elongation is equal to or greaterthan 0.8 N per cm width per percent elongation, in one embodiment 1.0 Nper cm width per percent elongation, in one embodiment equal to orgreater than 1.2 N per cm width per percent elongation, in oneembodiment equal to or greater than 1.4 N per cm width per percentelongation. In one embodiment, the difference quotient of tension intransverse direction from 20% elongation to 25% elongation equal to orless than 12 N per cm width per percent elongation, in one embodimentequal to or less than 10 N per cm width per percent elongation, in oneembodiment equal to or less than 8 N per cm width per percentelongation, in one embodiment equal to or less than 6 N per cm width perpercent elongation.

Main materials have a maximum elongation in said transverse directionfrom equal to or greater than 6% under a load of 10 N per cm width, inone embodiment equal to or greater than 7% under a load of 10 N per cmwidth. In one embodiment the main material has a maximum elongation insaid transverse direction from equal to or less than 27% under a load of10 N per cm width, in one embodiment equal to or less than 25% under aload of 10 N per cm width, in one embodiment equal to or less than 23%under a load of 10 N per cm width.

To facilitate comfort through e.g. lower supine (resting) pressures,main materials desirably have a difference quotient of tension intransverse direction from 15% elongation to 20% elongation that isshallower than the difference quotient of tension in transversedirection from 20% elongation to 25% elongation. In one embodiment, thedifference quotient of tension in transverse direction from 15%elongation to 20% elongation is equal to or less than 70% of thedifference quotient tension in transverse direction from 20% elongationto 25% elongation; in one embodiment equal to or less than 55% of thedifference quotient tension in transverse direction from 20% elongationto 25% elongation, in one embodiment equal to or less than 45% of thedifference quotient tension in transverse direction from 20% elongationto 25% elongation; in one embodiment equal to or less than 35% of thedifference quotient tension in transverse direction from 20% elongationto 25% elongation.

To facilitate desirable contour fitting of compression devices, inparticular sleeves thereof, desirably main materials have elasticity inthe longitudinal direction of the sleeve. More desirably main materialsshow anisotropic elasticity characteristics where they are easier tostretch in the longitudinal direction. In one embodiment main materialshave a ratio of tension in transverse direction at 30% elongation (or at30% elongation after a one minute hold) to tension in longitudinaldirection at 30% elongation (or at 30% elongation after a one minutehold) which is greater than 1.8, in one embodiment equal to or greaterthan 2.0, in one embodiment equal to or greater than 2.2.

In one embodiment, compression devices are configured and arranged suchthat the area of the central region is at least 40% (in particular atleast 45%, more particularly at least 50%) of the total area of thesleeve. In addition or alternatively thereto, compression devices may beconfigured and arranged such that at a height corresponding totwo-thirds the height of sleeve from the lower edge to the upper edge,the central region of the sleeve extends 40% or more across the sleevein its transverse direction.

In one embodiment, at least 85% (in particular at least 90%, moreparticularly at least 95%) of the total area of the central region ofthe sleeve is made of said main material.

It is to be appreciated that since compressions devices, in particularthe sleeves thereof will expand and/or change form in use, the aforesaidpercent areas and width are relative to respective areas and width inthe device when it is not in use. Further, it is to be appreciated thatthe sleeve, in particular the central region thereof, may comprise or bemade of a single material having the corresponding properties of a mainmaterial or alternatively one or more materials each having thecorresponding properties of a main material or alternatively one or morematerials in the form of a composite material (e.g. laminate) saidcomposite material having the corresponding properties of a mainmaterial.

As indicated above, compression devices described herein, in particularsleeves thereof, are particularly suited for covering a portion of alimb, a portion of the torso, a portion of the neck, a portion of a heador a portion of a neck and head in combination of a user e.g. for theuse in the treatment and/or management of oedema.

For compression devices for applying compression to a limb, the sleevemay be configured and arranged to cover a limb such that the sleeveextends over at least one major muscle of the limb. For example, forcompression devices designed for use on leg, said at least major musclemay be selected from the following: tibialis anterior, soleus,gastrocnemius, bicep femoris, rectus femoris, vastus medialis, vastusintermedius, vastus lateralis. It will be appreciated the first threelisted muscles are major muscles in the lower leg, while the latter fiveare major muscles in the upper leg (the last four forming the musclegroup called quadriceps femoris). Compression devices may be designedfor use on just the lower leg or just the upper leg, or alternativelyfor both the lower and upper leg. It will also be appreciated thattypically a combination of major muscles will be covered. Forcompression devices designed for use on arm, said at least major musclemay be selected from the following: flexor carpi radialis, flexor carpiulnaris, palmaris longus, brachioradialis, biceps brachii, tricepsbrachii, brachialis. It will be appreciated that the first four listedmuscles are major muscles in the lower arm, while the latter three aremajor muscles in the upper arm, and that the compression devices may bedesigned for use just on the lower arm or upper arm or alternatively forboth the lower and upper arm. Again it will also be appreciated thattypically a combination of major muscles will be covered.

The dependent claims define further embodiments of the invention.

It is to be understood that the present invention covers allcombinations of particular, suitable, desirable, favorable advantageousand preferred aspects of the invention described herein.

BRIEF DESCRIPTION OF DRAWINGS

The invention will now be described with reference to the accompanyingdrawings in which:

FIG. 1 represents a top view of an exemplary embodiment of a compressiondevice described herein, while FIG. 2 shows a cross-sectional view ofthe exemplary embodiment depicted in FIG. 1.

FIG. 3a represents a perspective, front view of the exemplary embodimentdepicted in FIGS. 1 and 2 shown in use on the lower leg of a user, whileFIG. 3b shows a projection of the axis R (which is depicted in FIG. 3a )onto a plane P containing the central axis A (that is also depicted inFIG. 3a ).

FIG. 4 represents a top view of another exemplary embodiment of acompression device described herein, while FIG. 5 shows across-sectional view of the exemplary embodiment depicted in FIG. 4.

FIG. 6 represents a top view of a further exemplary embodiment of acompression device described herein, while FIG. 7 shows across-sectional view of the exemplary embodiment in FIG. 6.

FIG. 8 represents a top view of yet another exemplary embodiment of acompression device described herein, while FIG. 9 shows across-sectional view of the exemplary embodiment in FIG. 8.

FIG. 10a shows a perspective, front view of the exemplary embodiment indepicted in FIGS. 8 and 9 in use on the lower leg of a user and FIG. 10bshows a projection of the axes G and R (which are depicted in FIG. 10a )onto a plane P containing the central axis A (that is also depicted inFIG. 10a ).

FIG. 11 represents a top view of an additional exemplary embodiment of acompression device described herein, while FIG. 12 shows across-sectional view of the exemplary embodiment in FIG. 11.

FIG. 13 represents a top view of prototype construction used fortesting, while FIG. 14 shows a cross-sectional view of the prototypeconstruction depicted in FIG. 13.

FIG. 15 a, b, d and e show SEM images and FIG. 15c a light microscopicimage of the warp knitted spacer fabric marketed by Gehring TextilesInc., Garden City, N.Y. 11530, USA under the trade designation SHR 700/3D3 D/O 7208810 (M1), where FIG. 15a shows the outer surface of one side(side 1); FIG. 15 b and c show the outer surface of the other side (side2); FIG. 15d shows a side view, machine direction and FIG. 15e shows aside view, cross direction.

FIG. 16 a to d show SEM images of the warp knitted spacer fabricmarketed by Müller Textil, 51674 Wiehl, Germany under the tradedesignation 3 Mesh 5992 (M2), where FIG. 16a shows the outer surface ofone side (side 1); FIG. 16b shows the outer surface of the other side(side 2); FIG. 16c shows a side view, machine direction and FIG. 16dshows a side view, cross direction.

FIG. 17 represent a plot of tensions versus percent elongation for thefive materials, M1, M2, CS1, CS2 and CS3, tested in the experimentalsection.

In the description that follows, unless expressly stated otherwise,terms such as ‘top’, ‘bottom’, ‘above’, ‘below’, etc, refer only tofeatures as shown in the Figures, and no restriction as to orientationof use, etc, is intended. Not all Figures are to the same scale.

DETAILED DESCRIPTION

It is to be understood that the present invention covers allcombinations of particular, suitable, desirable, favorable, advantageousand preferred aspects of the invention described herein.

FIG. 1 shows a top view of the exterior of an exemplary embodiment of acompression device (100) for use in applying compression to a body part,in particular a limb of a user, while FIG. 2 shows a cross-sectionalview of this exemplary embodiment. The device comprises a sleeve (1) forsubstantially covering a portion of the body part, in particular aportion of the limb of a user. The sleeve includes an outer surface (3),an inner surface (4), an upper edge (7) and a lower edge (8). When thedevice is in use on the limb, typically the inner surface (4) is locatedtowards the wearer/user. (In the following the term “inner” willtypically refer to something located towards the wearer/user and “outer”away from the wearer/user. For compression devices for use in applyingcompression to a limb, the upper edge will typically be located towardsto the torso of the user and the lower edge distant to the torso of theuser, and for compression device for use in applying compression to thetorso, neck or head, the upper edge will typically be located distant tothe legs and the lower edge towards the legs, and both upper and loweredges, being essentially transverse, will generally be locatedessentially circumferentially around the relevant body part afterapplication.) As mentioned above, after application of a compressiondevice onto a body part (e.g. a limb) of a user, the transversedirection of the sleeve will also be a circumferential direction. InFIG. 1, the transverse direction of the sleeve is indicated by thesymbols: T←→T, while the longitudinal direction of the sleeve isindicated by the symbols: L←→L. As can be appreciated from FIG. 1, thesleeve includes two lateral side edges (9, 10) extending from its upperedge to its lower edge. In the transverse direction of the sleeve (fromthe first lateral side edge (9) to the second lateral side edge (10) thesleeve comprises a first lateral side region (13), a central region (14)and a second lateral side region (15).

Sleeves, when laid out flat (e.g. as depicted in FIG. 1) may besubstantially rectangular, trapezoidal or irregular in shape. Forexample, the sleeves in a number of exemplary embodiments depictedherein (e.g. in FIG. 1) are substantially trapezoidal in shape. Forfacilitating an optimal fit onto a part of the body (e.g. a limb, torso,neck or head) of a user, the upper edge and/or the lower edge of thesleeve may be favorably slightly curved, in particular the upper edgemay be slightly convex and/or the lower edge may be either slightlyconcave or convex. Alternatively or in addition thereto, one or both ofthe lateral side edges may be slightly curved, in particular slightlyconvex. This may be facilitating fitting over well-developed calves. Inuse, when the compression device is applied onto a body part (e.g. alimb, torso, neck or head) of the user, favorably the sleeve issubstantially cylindrical, barrel or truncated-conical in shape.

Compression devices described herein further comprise a releasableclosure system. The closure system is configured and arranged relativeto the sleeve, such that, in use, upon closure of the closure system thesleeve is restrained and tightened about the body part (e.g. limb,torso, neck or head) of the user. Desirably the sleeve and closuresystem are configured and arranged such that in use, upon closure of theclosure system, the two lateral edges of the sleeve are drawn towardsone another, but do not overlap.

Releasable closure systems may include zippers, e.g. wherein the firstlateral edge of the sleeve may be provided with one half of said zipperand the second lateral edge is provided with a complementary half ofsaid zipper. The term “zipper” as used herein includes mechanicalclosure devices comprising two zipper-tape halves, each provided teethor other elements including (e.g. male and/or female) interlockingprofiles, which can interlocked together or disengaged from another viathe use of a slider to form a closed or opened zipper chain,respectively. An example of a toothless zipper includes the closuresystem marketed by GORE under the trade designation LOCKOUT whichincludes a slider that interlocks the two double channeled polymertracks.

Desirably releasable closure systems allow for individualized tightenalong the longitudinal direction of the sleeve. Examples of such systemsmay include closure systems comprising a plurality of opposing laceguides provided on the outer surface of two lateral side regions of thesleeve and a lace extending back and forth between the opposed guides.Such closure systems may further comprise at least one rotatabletightening mechanism configured to apply tension on the lace therebyadvancing the opposed guides towards each other. In particular the atleast one rotatable tightening mechanism may be integrally formed withat least one guide. Typically in such reel-lacing systems the lace hasno free end. Other examples of such releasable closure systems maycomprise a mechanical fastening closure system.

For example, the first lateral region or the second lateral region orboth regions may be provided with a plurality of tabs, wherein each tabcomprises a proximal end portion and a distal end portion, said proximalend portion being releasably or fixedly attached to the first lateraledge region and/or second lateral edge region of sleeve, respectively,such that the tab extends across the first lateral side edge and/or thesecond lateral side edge, respectively, in substantially the transversedirection of the sleeve, with its distal end portion positioned awayfrom the central portion of the sleeve. The inner major surface (i.e.that surface of the tab facing towards the wearer) of each tab at thedistal end portion of the tab may then comprise one part of a mechanicalfastening system (e.g. hook, stem and/or cup-shaped fasteners). At leastouter surface at the second and/or first lateral edge region,respectively, opposite to each tab may then comprise the complementarypart of the mechanical fastening system (e.g. said outer surface mayhave a structure or be provided with a structure that is adapted to beengaged by said fasteners). Such tabs may have a width relative to thetransverse direction of the sleeve of at least 6 cm. Such tabs may havea width relative to the transverse direction of the sleeve of at most 25cm. Such tabs may have a height relative to the transverse direction ofthe sleeve of at least 1 cm, in particular at least 2 cm, moreparticularly at least 3 cm. Such tabs may have a height relative to thetransverse direction of the sleeve of at most 10 cm, in particular atmost 8 cm, more particular at most 6 cm.

As mentioned above the proximal end of such tabs may be either fixedlyor releasably attached to the respective first and/or second lateralside region of the sleeve. When such tabs are releasably attached, innermajor surface at the proximal end portion of the tabs may be providedwith hook, stem and/or cup-shaped fasteners (second tab fasteners) andthe outer surface of the first and/or second lateral edge region of thesleeve may have a structure or be provided with a structure that isadapted to be engaged by said second tab fasteners.

Accordingly the inner major surface at the proximal end portion of thefastening tabs may be then releasably attached to the outer surface offirst and/or lateral edge region of the sleeve, respectively. The secondtab fasteners may be identical to the first tab fasteners or different.In the event that the second and first tab fasteners are different,favorably the outer surface at the first and second lateral edge regionsof the sleeve have a structure or are provided with a structure that isadapted to be engaged by both the first and second fasteners.

Another example of a releasable closure system comprise a mechanicalfastening closure system and favorably allow for individualized tightenalong the longitudinal direction of the sleeve includes systemsincluding fastening tabs in conjunction with rings or eyelets. Forexample the second lateral edge region of the sleeve may be providedwith either a plurality of eyelets or a plurality of rings in seriesbetween the upper and lower edges of the sleeve. The device may thenfurther comprise a plurality of strip-shaped mechanical fastening tabs,wherein a single fastening tab is provided for each eyelet or ring, asapplicable, each fastening tab comprising a proximal end portion and adistal end portion being connected by an inner tab portion, wherein saidproximal end portion is releasably or fixedly attached to the firstlateral edge region of sleeve such that the fastening tab is locatedopposite to an eyelet or ring, as applicable, and extends insubstantially the transverse direction of the sleeve with its distal endportion positioned away from the central portion of the sleeve, whereinthe outer major surface at the distal end portion of the fastening tabcomprises one part of a mechanical fastening system and said outer majorsurface at the proximal end portion of the fastening tab comprise thecomplementary part of the mechanical fastening system. Such fasteningtabs and eyelets or rings, as applicable, are configured and arrangedsuch that, in use, the tabs are passed through the eyelets or rings, asapplicable, then turned back on themselves such that the first lateralside edge of the sleeve is drawn towards the eyelets or rings, asapplicable, and then fastened so that the sleeve is tightened andrestrained about the body part (e.g. limb, torso, neck or head) of theuser. The exemplary embodiment shown in FIGS. 1 and 2 as well as otherexemplary embodiments discussed herein include such a releasable closuresystem.

Returning to the exemplary embodiment of FIGS. 1 and 2, it can be seenthat the second lateral edge region (15) of the sleeve (1) is providedwith a plurality of rings (16) (for ease in viewing only one ring islabelled with the reference number) in series between the upper andlower edges of the sleeve. Each ring is attached, in this particularexemplary embodiment fixedly attached by a strap (17) to the sleeve; thestraps extending in the transverse direction. The ring straps may bedirectly attached to the sleeve or alternatively via an intermediateconnecting element. In this particular exemplary embodiment, the strapsare connected to an intermediate elongate, castellated element (17 a)that is directly attached to sleeve, in particular onto the outersurface (3) of the sleeve at the second lateral side region. It will beappreciated that although in this exemplary embodiment, the rings andstraps are fixedly attached, in alternative embodiments straps theycould be releasably attached. The exemplary compression device (100)further comprises a plurality of strip-shaped mechanical fastening tabs(2) (again for ease in viewing only one fastening tab is labelled).There is a single tab provided for each ring (16). Each tab comprises aproximal end portion (22) and a distal end portion (24) being connectedby an inner tab portion (23). In this exemplary embodiment, the proximalend portion (22) is attached e.g. via adhesive, bonding, or stitching)to the first lateral edge region (13) of sleeve (1). It is to beappreciated that the proximal end portion could alternatively beingreleasably attached to the first lateral edge region of the sleeve (forexample as illustrated in other exemplary embodiments described herein).The fastening tabs (2) are attached onto the sleeve such that there is atab located opposite to a ring and such that each tab extends insubstantially the transverse direction of the sleeve, with its distalend portion (24) positioned away from the central portion of the sleeve.From FIG. 2, it can be seen that each tab has a first major surface,i.e. an inner major surface (34), located towards the outer surface (3)of the sleeve and a second major surface, i.e. an outer major surface(33), located away from the outer surface of the sleeve. The outer majorsurface (33) at the distal end portion (24) of the tab comprises onepart (25) of a mechanical fastening system and said second major surfaceat the proximal end portion of the tab comprises the complementary part(26) of the mechanical fastening system. As can be seen in thisexemplary embodiment shown in FIGS. 1 and 2 and the other exemplaryembodiments described herein, the second major surface at the inner tabportion of the fastening tab may also comprise the complementary part(26) of the mechanical fastening system.

Referring to FIG. 3a showing a perspective, front view of the exemplarycompression device (100) depicted in FIGS. 1 and 2, in use on the lowerleg of a user, it can be recognized that the fastening tabs (2) andrings (16) are configured and arranged such that, in use, the fasteningtabs are passed through the rings, turned back on themselves such thatthe first lateral side edge (9) of the sleeve (1) is drawn towards therings and finally fastened so that the sleeve is tightened andrestrained about the limb of the user to provide compression. Oncepositioned onto the limb of the user, the compression device (100)advantageously encircles the relevant portion of the limb and, in thisexemplary embodiment the sleeve (1) and in particular the central region(14) of the sleeve will encircle most of the limb.

In general, such fastening tabs (i.e. fastening tabs that are turnedback on themselves during fastening) are favorably configured such thatthe second major surface at the distal end portion of the fastening tabsis provided with hook, stem and/or cup-shaped fasteners (first tabfasteners) and the second major surface at the proximal end portion ofthe fastening tabs has a structure or is provided with a structure thatis adapted to be engaged by said first tab fasteners.

The second major surface at the inner portion of the fastening tabs mayalso have a structure or be provided with a structure that is adapted tobe engaged by the first tab fasteners. Favorably such fastening tabs areattached to the first lateral side region such that the fastening tabsextend across the first lateral side edge, in particular the fasteningtabs extend at least 2 cm outwardly beyond said side edge.

For embodiments including a plurality of eyelets or rings, asapplicable, favorably the interstices between eyelets or rings,respectively, extends over a height corresponding to at least 70% of theheight of the sleeve from the upper to lower edge. The height of theinterstices between eyelets and rings, as applicable, may range from 0.1mm to 7 cm, inclusive, in particular from 0.3 mm to 3 cm, inclusive, andmore particular from 0.5 mm to 2 cm.

As will be appreciated from the exemplary embodiment shown in FIGS. 1and 2 and the other exemplary embodiments described herein, tofacilitate application and an overall smooth fit of the device, eyeletsand rings, as applicable, are favorably configured and/or selected, suchthat the opening of the eyelet or ring has a height relative to thetransverse direction of the sleeve which is greater than the heightrelative to the transverse direction of the sleeve of the fastening tab.And for those embodiments including rings and straps, favorably therings are configured and/or selected, such that the opening of the ringhas a height relative to the transverse direction of the sleeve which isgreater than the height relative to the transverse direction of thesleeve of the strap. In addition or alternatively, eyelets and rings, asapplicable, are desirably rectangular or substantially rectangular inform; or oval or substantially oval in form (e.g. narrow or elongateoval, canoe-form, elongate teardrop); or a elongate or narrow D-shape inform. Rings are favorably positioned along the (first or second) lateraledge of the sleeve either adjacent to or spaced apart from said edge andaway from the (first or second) lateral edge portion, in particularwherein each ring has a lateral edge near the (first or second) lateraledge of the sleeve, said lateral edge of the ring is either positionedadjacent to (first or second) lateral edge of the sleeve or spaced apartfrom the (first of second) second lateral edge at a distance of at most4 cm, in particular at most 3 cm.

Fastening tabs desirably have a height relative to the transversedirection of the sleeve of at least 1 cm, more favorably as least 2 cm.more desirably at least 3 cm. Fastening tabs desirably have a heightrelative to the transverse direction of the sleeve of at most 10 cm,more desirably at most 8 cm, most desirably at most 6 cm. Fastening tabsdesirably have a width relative to the transverse direction of thesleeve of at least 6 cm. Fastening tabs desirable have a width relativeto the transverse direction of the sleeve is at most 25 cm.

Straps desirably have a height relative to the transverse direction ofthe sleeve of at least 1 cm, more desirably at least 2 cm, mostdesirably at least 3 cm. Desirably straps have a height relative to thetransverse direction of the sleeve of at most 10 cm, more favorably atmost 8 cm, most favorably at most 6 cm. The height of the intersticesbetween straps may range from 0.3 mm to 7 cm, inclusive, in particularfrom 0.3 mm to 3 cm, inclusive, and more particular from 0.5 mm to 2 cm.

As it can be appreciated from exemplary embodiment shown in FIGS. 1 to 3a, it may be desirable to configure and arrange the sleeve, eyelets orrings, as applicable, and fastening tabs, such that in use, when thefastening tabs are passed through the eyelets or rings, as applicable,turned back and fastened onto themselves, the first lateral edge isdrawn towards the second lateral edge of the sleeve, but the two lateraledges of the sleeve do not overlap. Also as it can be appreciated fromthe exemplary embodiment shown in FIGS. 1 to 3 a, compression devicesmay further comprise a tongue. The tongue is desirably configured andarranged relative to the sleeve such that, in use, the tongue isgenerally centrally positioned adjacent to and extends along the firstand second lateral edges of the sleeve, so that the tongue is locatedbetween the user and an opening defined between the first and secondlateral edges of the sleeve and so that the tongue underlies at least aportion (typically that portion adjacent to the first and second lateraledges) of each the first and second lateral side regions.

For compression devices including a tongue, the tongue may comprisefoam, in particular memory foam, more particular high density memoryfoam. High density memory foams are memory foams that have a density ofat least 65 kg/m³, in particular at least 70 kg/m³, more particularly atleast 85 kg/m³, most particularly at least 105 kg/m³. Examples ofsuitable memory foams include high density memory foams available fromFiltrona Porous Technologies marketed under the trade designations SRFEP2, Argus, Argus Soft, and Argus Supersoft. Favorably the tonguecomprises one or more layers of foam, in particular a layer of foamhaving a thickness from 0.5 mm to 10 mm, inclusive, more particular alayer of foam having a thickness from 2 mm to 6 mm, inclusive.Alternatively or in addition, tongues may favorably include a stiffener,e.g. in the form of elongate wires, bars, grids, or pads. Tongues mayinclude either a single stiffener extending substantially across itswidth and length or one or more stiffeners extending lengthwise providedin series across the width of the tongue.

Compression devices, in particular sleeves, more particularly the firstand/or second lateral side regions thereof, may also be provided withone or more stiffeners to facilitate maintenance of sleeve shape, inparticular to minimize any tendency towards vertical collapsing orslipping-down of the sleeve, stiffeners may be provided e.g. in the formof wires, bars, grids, or pads having limited width relative to thetransverse direction of the sleeve. In the exemplary embodiment depictedin FIGS. 1 and 2, for example, an elongate stiffener (32) that extendslengthwise between the upper and lower edges of the sleeve is providedin the second lateral side region (15) adjacent to the second lateraledge (10).

Stiffeners may be made of e.g. metal or thermoplastic materialsincluding thermoformable thermoplastic materials (such as polypropylene,polyamide, polyester (e.g. 3M Scotchcast Thermoplastic Material 72362)).For stiffeners having a width greater than five millimeters, it may befavorable to provide them with perforations to allow for breathability.For design and/or fixing purposes, stiffeners may be provided within afabric pocket which is subsequently attached to the appropriate part(s)of the sleeve or tongue, as the case may be; or alternatively stiffenersmay be positioned on the surface of the appropriate part(s) of thesleeve or tongue, as applicable, which are then covered completely witha sheet of fabric that is sewn or laminated onto the respective part(s)of the sleeve or tongue, as applicable.

Returning to the exemplary embodiment depicted in FIGS. 1 and 2, it canbe seen that elongate stiffener (32) that extends lengthwise between theupper and lower edges of the sleeve is provided in the second lateralside region (15) adjacent to the second lateral edge (10). The stiffeneris covered with a piece of fabric (32 a). It can also be seen that theexemplary compression device (100) includes a tongue (5). The tongue, inparticular a lateral edge portion thereof, is affixed to the innersurface (4) at the second lateral edge region (15) of the sleeve so thatthe tongue extends beyond the second lateral edge (10) and underlies therings (16). Referring to FIG. 3a , it can be recognized that the sleeve(1) and fastening tabs (2) of the exemplary compression device (100),are configured and arranged, such that in use, when the fastening tabsare passed through the eyelets or rings, as applicable, turned back andfastened onto themselves, the first lateral edge (9) is drawn towardsthe second lateral edge (10) of the sleeve, but the two lateral edges ofthe sleeve do not overlap. In addition it can be seen in FIG. 3a , thatwhen the compression device (100) is in use on the body part, here thelimb, of the user, the tongue (5) is generally centrally positionedadjacent to and extends along the first and second lateral edges (9, 10)of the sleeve (1), so that the tongue is located between the user and anopening defined between the first and second lateral edges of the sleeveunderlying at least in part the first and second lateral edge regions.Also it can be recognized in FIG. 3a , that when the exemplarycompression device (100) is in use on the limb of the user, the sleeveis disposed about a central axis (A) and the plurality of rings extendsalong a second axis (R). Making reference to FIG. 3b it can be seen thatrelative to a projection of the second axis (R) onto said plane (P)containing the central axis (A), the second axis (R) is in parallel oressentially parallel alignment relative to the central axis.

For those embodiments including a plurality of rings or eyelets, when inuse on the body part (e.g. limb, torso, neck or head) of the user, thesleeve will be disposed about a central axis (A), said central axislying in a plane (P), and the plurality of rings or eyelets extendsalong a second axis (R), wherein relative to a projection of the secondaxis (R) onto said plane (P) containing the central axis (A), the secondaxis is either in parallel alignment relative to the central axis ornearly parallel alignment relative to the central axis (i.e. the secondaxis (R) may be inclined forming an acute angle of no more than 5°relative to the central axis). It is to be appreciated that when thecompression device is in use on the body part of the user, it ispossible that the series of rings or eyelets may not extend along aperfectly straight axis, i.e. its projection may be curved due totension and particular geometry of the relevant body part of the user,and in such cases the relevant axis along which the series of ringsextends may be defined as being the axis resulting from a best linearfit (linear regression) to the projected curve.

As can be appreciated from FIG. 3a , for compression devices suitablefor use with the lower leg of the user, favorably the sleeve isconfigured and arranged such that in use the rings, or for thoseembodiments having eyelets, the eyelets, will generally be positionedtowards the front, in particular so that they extends generally alongthe tibia. Accordingly for such embodiments the central region of thesleeve will typically be positioned around the back and, at least on oneof the sides of the lower leg, and thus accordingly next to the calfmuscles.

Compression devices described herein are particularly useful forapplying compression to a limb. Desirably the sleeve is configured andarranged to cover a limb such that the sleeve extends over at least onemajor muscle of the limb. For example, for compression devices designedfor use on a leg (e.g. the lower leg and/or the upper leg), said atleast major muscle may be appropriately selected from the following:tibialis anterior, soleus, gastrocnemius, bicep femoris, rectus femoris,vastus medialis, vastus intermedius and vastus lateralis; while forcompression devices designed for use on an arm (e.g. the lower armand/or the upper arm) said at least major muscle may be appropriatelyselected from the following: flexor carpi radialis, flexor carpiulnaris, palmaris longus, brachioradialis, biceps brachii, tricepsbrachii, and brachialis. As mentioned previously, typically acombination of major muscles will be covered.

Compression devices described herein, in particular the sleeves thereof,can be provided in different sizes to accommodate the difference in thesize of body parts (e.g. limbs versus torsos or necks or heads; or e.g.relative to just limbs, arms versus legs) as well as the generaldifference in sizes of a particular body part. Compression devicessuitable for use with necks and heads will often be used for both, i.e.configured to cover a portion of both the neck and head of the user.Such devices may be configured for example like a hood covering theneck, chin and over the head leaving the face free where the releasableclosure system may be provided either along the top and back of the heador along the front down the chin and front of the neck.

Compression devices described herein are particularly suitable for useon limbs, in particular the lower leg including the calf (e.g. fortreating among other things venous leg ulcers and lymphoedema of theleg). In regard to the latter, for example considering the size of anadult human lower leg, including those persons suffering fromlymphodemia, can range from around 130 to 420 mm in circumference at theankle and around from 280 to 650 mm in circumference at their widestpoint, it could be possible to provide compression devices in forexample seven standard (width) sizes, e.g. XS, S; M, L, XL, XXL, XXXL,aimed to cover 80% of the potential relevant circumferential sizes ofthe potential users while the remaining 20% could be provided for byspecial order. In addition, considering the length of an adult humanlower leg can range from around 20 cm to 40 cm, it could be possible toprovide in conjunction with the standard (width) sizes mentioned above,three height sizes, e.g. short, average and, tall, again aimed to cover80% of the potential relevant lengths of the potential users. In regardto the standard width sizes, the number of standard sizes to cover 80%the potential relevant circumferential sizes of the potential userscould be reduced by for example providing compression devices configuredsuch that the width of the sleeve could be readily adjusted by the useror the care-giver applying the compression device onto the limb of theuser. In particular, it would be advantageous to provide compressiondevices wherein the fastening tabs is releasably attachable to the firstlateral edge region of the sleeve as described herein and wherein thefirst lateral edge region of the sleeve is configured such that it istrimmable. The exemplary embodiments depicted in FIGS. 4 to 12 anddiscussed in more detail provide examples of such compression devices.

From FIG. 2, it will be noted that the three regions (13, 14, and 15) ofthe sleeve comprise the same material (30). This material is the mainmaterial. Further it should be appreciated due to the attachment of astiffener (32), the ring-straps (17) and tongue (5) to the sleeve at thesecond lateral side region (15) and the attachment of fastening tabs (2)at the first lateral side region (13), the properties of the underlyingmain material (30) in these two regions will normally be affected.Moreover typically the maximum elongation in the transverse directionunder a load of 10 N per cm of the first and/or second lateral sideregions will be lower (most often significantly lower approaching andpossibly reaching 0% elongation) than the maximum elongation in thetransverse direction under a load of 10 N per cm of the central regionof the sleeve. Finally it will be appreciated that in the central regionof the sleeve, this region being free of such attachments, theproperties of the main material remain un-affected.

As indicated above, at least the central region of the sleeve comprisesa material (i.e. main material) having elasticity in at least thetransverse direction of the sleeve, a maximum elongation in saidtransverse direction from 5% up to and including 30% under a load of 10N per cm width, a difference quotient of tension in transverse directionfrom 20% elongation to 25% elongation equal to or greater than 0.6 N percm width per percent elongation.

In one embodiment, the difference quotient of tension in transversedirection from 20% elongation to 25% elongation is equal to or greaterthan 0.8 N per cm width per percent elongation, in one embodiment 1.0 Nper cm width per percent elongation, in one embodiment equal to orgreater than 1.2 N per cm width per percent elongation, in oneembodiment to or greater than 1.4 N per cm width per percent elongation.In one embodiment, the difference quotient of tension in transversedirection from 20% elongation to 25% elongation equal to or less than 12N per cm width per percent elongation, in one embodiment equal to orless than 10 N per cm width per percent elongation, in one embodimentequal to or less than 8 N per cm width per percent elongation, mostfavorably equal to or less than 6 N per cm width per percent elongation.

In one embodiment, main materials have a maximum elongation in saidtransverse direction from equal to or greater than 6% under a load of 10N per cm width, in one embodiment equal to or greater than 7% under aload of 10 N per cm width. In one embodiment, the main material has amaximum elongation in said transverse direction from equal to or lessthan 27% under a load of 10 N per cm width, in one embodiment equal toor less than 25% under a load of 10 N per cm width, in one embodimentequal to or less than 23% under a load of 10 N per cm width.

As indicated above, to facilitate comfort through e.g. lower supine(resting) pressures, main materials desirably have a difference quotientof tension in transverse direction from 15% elongation to 20% elongationthat is shallower than the difference quotient of tension in transversedirection from 20% elongation to 25% elongation. In one embodiment, thedifference quotient of tension in transverse direction from 15%elongation to 20% elongation is equal to or less than 70% of thedifference quotient tension in transverse direction from 20% elongationto 25% elongation; in one embodiment equal to or less than 55% of thedifference quotient tension in transverse direction from 20% elongationto 25% elongation, in one embodiment equal to or less than 45% of thedifference quotient tension in transverse direction from 20% elongationto 25% elongation; in one embodiment equal to or less than 35% of thedifference quotient tension in transverse direction from 20% elongationto 25% elongation.

In one embodiment, main materials have a differential quotient oftension in transverse direction from 25% elongation to 30% elongation isequal to or greater than 1.2 N per cm width per percent elongation, inone embodiment equal to or greater than 1.8 N per cm width per percentelongation, in one embodiment equal to or greater than 2.4 N per cmwidth per percent elongation, in one embodiment equal to or greater than3.0 N per cm width per percent elongation. In one embodiment, mainmaterials have a difference quotient of tension in transverse directionfrom 25% elongation to 30% elongation equal to or less than 24 N per cmwidth per percent elongation, in one embodiment equal to or less than 20N per cm width per percent elongation, in one embodiment equal to orless than 16 N per cm width per percent elongation, in one embodimentequal to or less than 12 N per cm width per percent elongation.

Main materials in one embodiment show a tension in transverse directionat 30% elongation or at 30% elongation, after a one minute hold, equalto or greater than 10 N per cm width, in one embodiment equal to orgreater than 15 N per cm width, in one embodiment equal to or greaterthan 20 N per cm width, in one embodiment equal to or greater than 25 Nper cm width. In one embodiment, main materials show a tension intransverse direction at 30% elongation or at 30% elongation, after a oneminute hold, equal to or less than 55 N per cm width, in one embodimentequal to or less than 50 N per cm width, in one embodiment equal to orless than 45 N per cm width, most particularly equal to or less than 40N per cm width.

Desirably main material have a recovered elongation in transversedirection equal to or greater than 80%, in particular equal to orgreater than 85%, more particularly equal to or greater than 90%, mostparticularly equal to or greater than 95%.

To facilitate the minimization and/or avoidance of compression devicefatigue, main materials in one embodiment show an elongation rise intransverse direction equal to or less than 3.5%.

Desirably main materials are rather flexible to facilitate applicationas well as general fitting of the sleeve onto the relevant portion ofthe body part (e.g. limb, torso, neck, or head). In one embodiment, mainmaterials show a bending length in the transverse and/or thelongitudinal direction equal to or less than 20 cm, in particular equalto or less than 15 cm; in one embodiment equal to or less than 10 cm, inone embodiment equal to or less than 5.0 cm. Alternatively or inaddition, in one embodiment main materials show a flexural rigidity inthe transverse and/or the longitudinal direction equal to or less than150 mN·cm, in one embodiment equal to or less than 125 mN·cm; in oneembodiment equal to or less than 75 mN·cm, in one embodiment equal to orless than 35 mN·cm.

As indicated above, to facilitate desirable contour fitting ofcompression devices, in particular sleeves thereof, desirably mainmaterials have elasticity in the longitudinal direction of the sleeve.In one embodiment, main materials show anisotropic elasticitycharacteristics where they are easier to stretch in the longitudinaldirection. In one embodiment, main materials have a ratio of tension intransverse direction at 30% elongation (or at 30% elongation after a oneminute hold) to tension in longitudinal direction at 30% elongation (orat 30% elongation after a one minute hold) which is greater than 1.8, inone embodiment equal to or greater than 2.0, in one embodiment equal toor greater than 2.2.

In one embodiment, main materials have a water vapor transmission rateequal to or greater than 2000 g/(m²0.24 hours), in one embodiment equalto or greater than 2200 g/(m²0.24 hours) from its inner to outersurface.

In one embodiment, main materials comprise a fibrous fabric, inparticular a woven or knitted fabric, in one embodiment a knitted spacerfabric. Knitted spacer fabrics are three-dimensional knitted fabricshaving two knitted substrates (e.g. a top layer and a bottom layer)which are joined together by spacer yarns (as an intermediate connectinglayer). In one embodiment, such fabrics, in particular knitted spacerfabrics, have a basis weight equal to or greater than 100 g/m², in oneembodiment equal to or greater than 150 g/m², in one embodiment equal toor greater than 200 g/m², in one embodiment equal to or greater than 250g/m². In addition or alternatively thereto, such fabrics, in particularknitted spacer fabrics, have a thickness equal to or greater than 0.5mm, in one embodiment equal to or greater than 1.0 mm, in one embodimentequal to or greater than 1.4 mm, and in one embodiment equal to orgreater than 1.8 mm. In addition or alternatively thereto, such fabrics,in particular knitted spacer fabrics, may have a thickness equal to orless than 6.0 mm, in one embodiment equal to or less than 5.2 mm, in oneembodiment equal to or less than 4.4 mm, and in one embodiment equal toor less than 3.6 mm. To minimize or avoid creation of impressions on theskin and/or a potential of skin irritation, in one embodiment fabrics,in particular knitted spacer fabrics, do not have large open patterns onthe side of the fabric that will be facing the skin; in one embodimentat least in one direction (e.g. machine or cross direction) the breadthof opening(s) is equal to or less than 3 mm. In the other direction(e.g. cross or machine direction, respectively) the breadth may be equalto or less than 3 mm or alternatively greater than 3 mm. Warp knittedspacer fabrics have been found to be suitable. Warp-knitted spacerfabrics are typically knitted on a rib raschel machine having two needlebars. Examples of suitable warp-knitted spacer fabrics include thespacer fabric marketed by Gehring Textiles Inc., Garden City, N.Y.11530, USA under the trade designation SHR 700/3 D3 D/0 7208810 and thespacer fabric marketed by Müller Textil, 51674 Wiehl, Germany under thetrade designation 3 Mesh 5992.

Compression devices may be configured and arranged such that the area ofthe central region is at least 40% (in particular at least 45%, moreparticularly at least 50%) of the total area of the sleeve (when thedevice is not in use). In addition or alternatively thereto, compressiondevices may be configured and arranged such that at a heightcorresponding to two-thirds the height of sleeve from the lower edge tothe upper edge, the central region of the sleeve extends 40% or moreacross the sleeve in its transverse direction (when the device is not inuse).

In one embodiment, at least 85% (in particular at least 90%, moreparticularly at least 95%) of the total area of the central region ofthe sleeve is made of said main material (when the device is not use).

In the event the first and/or second lateral side regions include thesame material as the central region, said material having thecorresponding properties of a main material, due to the provision of therespective parts of the releasable closure system, attachment of anoptional tongue and/or stiffeners generally the respective regions willnot have the corresponding properties of a main material. As indicatedabove, typically the maximum elongation in the transverse directionunder a load of 10 N per cm of the first and/or second lateral sideregions of the sleeve will be lower (most often significantly lowerapproaching and possibly reaching 0% elongation) than the maximumelongation in the transverse direction under a load of 10 N per cm ofthe central region of the sleeve. In the event, the first and/or secondlateral side regions do not comprise main material, but another materialor materials, again relative to the device as a whole including thereleasable closure system elements and/or other elements provided on thefirst and/or second lateral side regions, desirably the first and secondlateral side regions are not more stretchable in the transversedirection than the central region. Moreover in one embodiment the firstlateral side region and the second lateral side region show a maximumelongation in the transverse direction under a load of 10 N per cm thatis equal to or less than the maximum elongation in the transversedirection under a load of 10 N per cm in the central region of thesleeve. It will be appreciated that first lateral side region and/or thesecond lateral side region may show a maximum elongation in thetransverse direction under a load of 10 N per cm down to 0%. In additionor alternatively thereof, the first lateral side region and the secondlateral side region may show a maximum elongation in the longitudinaldirection under a load of 10 N per cm that is equal to or less than themaximum elongation in the longitudinal direction under a load of 10 Nper cm in the central region of the sleeve. Similarly it will beappreciated that first lateral side region and/or the second lateralside region may show a maximum elongation in the longitudinal directionunder a load of 10 N per cm down to 0%,

FIG. 4 shows a top view of the exterior of another exemplary embodimentof a compression device (100) for use in applying compression to a bodypart, in particular a limb, of a user, while FIG. 5 shows across-sectional view of this exemplary embodiment. The device comprisesa sleeve (1) for substantially covering a portion of the body part, inparticular the limb, of a user, including an outer surface (3), an innersurface (4), an upper edge (7) and a lower edge (8) as well as twolateral side edges (9, 10) extending from its upper edge to its loweredge where in the transverse direction from the first lateral side edge(9) to the second lateral side edge (10) the sleeve comprises a firstlateral side region (13), a central region (14) and a second lateralside region (15). The second lateral edge region of the sleeve isprovided with a plurality of rings (16) in series between the upper andlower edges of the sleeve. Each ring is attached, in this particularexemplary embodiment fixedly attached, by a strap (17) that extends insubstantially the transverse direction of the sleeve between the ringand the sleeve, in particular between the ring and the second lateralside region. Referring to the cross-sectional view in FIG. 4, it can beseen that the strap (17) is attached to the second lateral side region(15) of the sleeve (1), in particular onto the outer surface (3) of thesleeve at the second lateral side region. An elongate stiffener (32)that extends lengthwise between the upper and lower edges of the sleeveis provided at the proximal ends of the straps, i.e. in the secondlateral side region (15) adjacent to the second lateral edge (10). Theexemplary embodiment includes a tongue (5) attached at one of itslateral side edge to the inner surface (4) of the sleeve at the secondlateral side region (15). Referring to FIG. 5, the tongue includes twoelongate stiffeners (32) located between an inner foam layer (6) andouter fabric cover (26). The exemplary compression device furthercomprises a plurality of strip-shaped mechanical fastening tabs (2), onefor each ring (16).

As indicated above, the exemplary embodiment in FIGS. 4 and 5 differsfrom the exemplary embodiment shown in FIGS. 1 to 3 a in that thefastening tabs are releasably attached onto the outer surface at thefirst lateral side region (13) of the sleeve. Moreover, looking at theexemplary embodiment depicted in the FIGS. 4 and 5, it can be seen thatthe outer major surface (33) at the distal end portion (24) of eachfastening tab (2) is provided with hook, stem and/or cup-shapedfasteners (25) and the outer major surface at the proximal end portion(22) as well as at the inner tab portion (23) of the fastening tabs hasa structure or is provided with a structure (26) that is adapted to beengaged by said tab fasteners. In addition, the inner major surface (34)at the proximal end portion (22) of each fastening tab (2) is providedwith hook, stem and/or cup-shaped fasteners (27) (these second tabfasteners may be identical or different to the first tab fasteners (25))and the outer surface (3) at the first lateral side region (13) of thesleeve (1) has a structure or is provided with a structure (28) that isadapted to be engaged by the second tab fasteners (27). As can beappreciated from FIG. 4, typically the first lateral side region (13) isprovided with the relevant engagement structure (28) by laminating anappropriate layer of material onto the relevant region of the sleeve. Inaddition, the first lateral side region (13) can be easily trimmed alongits outer edge. In the event, it is needed or desired to reduce thewidth or circumference of the compression device, in particular thesleeve thereof, the fastening tabs can be detached, an appropriateamount of the first lateral side region can be trimmed off, so as toachieve the needed or desired width/circumference. Thereafter thefastening tabs can be re-attached to the remaining portion of the firstlateral side region, and the device applied. Generally, the tabs areattached to the outer surface of the sleeve such that the tabs extendacross the first lateral side edge, in particular so that their distalend portions are displaced from first lateral side edge.

From FIG. 5, it will be appreciated that like the exemplary embodimentdepicted in FIGS. 1 and 2, the three regions (13, 14, and 15) of thesleeve comprise the same material (30), i.e. main material. Similar tothe first exemplary embodiment, due to the attachment of a stiffener(32), the ring-straps (17) and tongue (5) to the sleeve at the secondlateral side region (15) the properties of the underlying main materialin this region will be normally affected (i.e. the maximum elongation inthe transverse direction under a load of 10 N per cm of the sleeve inthe second lateral side region will be lower (often significantly lowerapproaching 0%) than the maximum elongation in the transverse directionunder a load of 10 N per cm of the sleeve in the central region). Due tolamination of the fastener-engagement material (28) onto the outersurface at the first lateral side region (13), the properties of theunderlying main material in this region may be affected. Moreover theoverall properties of the first lateral side region will accordinglydepend on the properties of the fastener-engagement material and thusthe properties of the resulting laminate including thefastener-engagement-material and main material. In one embodiment, thefastener-engagement material and lamination method is selected so thatthe properties of the main material dictate the overall properties ofthe first regional side region. Nonetheless a number of thefastener-engagement materials available on the market are inelastic oressentially inelastic. If the applied fastener-engagement material isinelastic or (if not inelastic per se) has a lower maximum elongationunder a load of 10 N per cm than the main material, it will beappreciated that the maximum elongation in the transverse directionunder a load of 10 N per cm of the sleeve in the first lateral sideregion will be either zero or (if not zero) lower than the maximumelongation in the transverse direction under a load of 10 N per cm ofthe sleeve in the central region.

The exemplary embodiment in FIGS. 4 and 5 also differs from theexemplary embodiment shown in FIGS. 1 to 3 a in that the strapsfavorably comprise a loop-indicating configuration.

For embodiments including rings with straps, it is favorable that atleast a portion of said strap is expandable in at least the transversedirection, said expandable portion comprising a material havingelasticity in at least the transverse direction and being configured andarranged, such that when the expandable portion is in its non-expandedstate there is exteriorly a loop of material rising outwardly and when,in use under the provision of tension in the transverse direction of thesleeve, the expandable portion expands in the transverse direction andthe loop flattens. This expandable portion having in its non-expandedstate a loop of material to the exterior and rising outwardly, which inuse under the provision of tension in the transverse direction of thesleeve, expands in the transverse direction so that the loop flattens(eventually disappearing) is termed herein as a loop-indicatingconfiguration. Such a loop-indicating configuration advantageouslyprovides a visual indication towards the extent of extension, thusfacilitating assessment of the extent of extension and the provision ofa good anatomic fit. Moreover, when there is no extension or onlypartial extension of the expandable strap portion, the outwardly facingloop will be fully raised or only partly flatten, and thus visible assuch, and when there is full extension of the expandable strap portionthe outwardly facing loop will disappear (i.e. it will flatten to suchan extent there is no longer a loop of material rising outwardly). Sucha visual indication is advantageous during the application because oncethe loop fully flattens out (and thus disappears) there is fullextension and thus an indication towards sufficient anatomical fit.Moreover, by providing such a loop-indicating configuration in thestraps of the plurality of rings that are provided in series between theupper and lower edges of the sleeve or in the elongate, expandablegusset that extends substantially lengthwise between the upper and loweredges of the sleeve, it is possible to have a visual indication towardsextent of extension and thus fit over respective height of the sleevebetween its upper and lower edges, so that if desired and/or needed, theextent of tightening of an individual fastening tab threaded through itsopposing ring or eyelet can adjusted facilitating the provision of adesirable anatomic fit over the portion of the body part (e.g. limb,torso, neck, head) of a user covered by the sleeve and thus in turnfacilitating uniformity of compression. The loop-indicatingconfiguration is also useful while the user is wearing the compressiondevice. For example, if, as in fact is desired, the volume of the bodypart (e.g. limb, torso, neck or head) is reduced for example as a resultof oedema reduction due to effective compression therapy, the extent oftension on the device and on the expandable strap-portion will bereduced and the previously flattened loop will then noticeably puckeroutwardly forming a fully raised or somewhat flattened loop, dependingon the extent of reduced tension and thus providing an indication thatthe device should be re-tightened or re-applied.

In one embodiment, the product of the modulus of elasticity of the loopmaterial times the thickness of the loop material is at least 90% of theproduct of the modulus of elasticity of said main material times thethickness of the main material, in particular the product of the modulusof elasticity of the loop material times the thickness of the loopmaterial is equal to or greater than the product of the modulus ofelasticity of said main material times the thickness of the mainmaterial.

In FIGS. 4 and 5, it can be seen that each strap (17) include anexpandable portion (21) that is configured with a loop (20) towards theexterior and rising outwardly. This is best seen in cross-sectional viewshown in FIG. 5 which like FIG. 4 shows the exemplary compression not inuse and thus shows the expandable strap portion in its non-expandedstate. It can also be seen that the expandable portion of the strapfavorably comprises two layers, an outer layer of material (18) and aninner layer of material (19) where both the inner-layer-material andouter-layer-material have elasticity in at least the transversedirection and wherein the inner layer of material is affixed to theouter layer of material, so as to provide a loop of outer-layer-material(i.e. loop (20)) above the inner layer. As result of this elasticity,the configuration of the attachment of the inner andouter-layer-materials to one another as well as the configuration of theattachment of the strap to the ring and onto the sleeve, theloop-containing portion (21) of the strap is expandable in at least thetransverse direction. When the expandable portion of the strap is notexpanded, i.e. in its non-expanded state, as shown in FIGS. 4 and 5, theloop (20) is visible as an elongate mound or hump. In use, when thedevice is applied onto the body part, in particular the limb, of a user,tension will be provided and accordingly the expandable portion (21) ofthe strap will expand in the transverse direction and the loop can andwill flatten.

For those embodiments where the expandable portion of the strap includestwo layers, favorably the product of the modulus of elasticity (in thetransverse direction) of the inner-layer-material times the thickness ofthe inner-layer material is less than the product of the modulus ofelasticity (in the transverse direction) of the outer-layer-materialtimes the thickness of the outer-layer material. In one embodiment, theproduct of the modulus of elasticity of the inner-layer-material timesthe thickness of the inner-layer-material is at least a factor of twotimes, in one embodiment at least a factor of four times, lower theproduct of the modulus of elasticity of the outer-layer-material timesthe thickness of the outer-layer-material.

Generally, for compression devices including rings and straps having anexpandable portion with a loop-indicating configuration as describedabove, desirably said expandable portion of the strap has in itsnon-expanded state a width relative to the transverse direction of thesleeve of at least 0.1 cm, in particular at least 0.5 cm. Desirably theexpandable portion of the strap has in its non-expanded state a widthrelative to the transverse direction of the sleeve of at most 4 cm, moredesirably at most 3 cm. In one embodiment, the expandable portion of thestrap has in its expanded state at the point where the loop just fullyflattens out a width relative to the transverse direction of the sleeveof at least 1 cm. In one embodiment, the expandable portion of the straphas in its expanded state at the point where the loop just fullyflattens out a width relative to the transverse direction of the sleeveof at most 8 cm, more favorably at most 6 cm.

FIGS. 6 to 12 depict exemplary embodiments where the loop-indicatingconfiguration is provided in an elongate, expandable gusset that extendssubstantially lengthwise between the upper and lower edges of thesleeve. Generally, for compression devices that include such a gusset,the gusset favorably extends a height corresponding to 70% up to 100% ofthe height of the sleeve from the upper to lower edge, more favorablythe gusset extends from the upper to lower edges of the sleeve. Similarto the expandable portion of the strap described above, gussets comprisea material having elasticity in at least the transverse direction in thesleeve and are configured and arranged such that when the gusset is inits non-expanded state (e.g. when the compression device is not in use)there is to the exterior of the device a loop of material risingoutwardly and when in use under the provision of tension in thetransverse direction of the sleeve, the gusset expands in the transversedirection and the loop flattens (eventually disappearing).

FIG. 6 shows a top view of the exterior of an exemplary embodiment of acompression device (100) for use in applying compression to a body part,in particular a limb, of a user including instead of rings, eyelets,while FIG. 7 shows a cross-sectional view of this exemplary embodiment.The device comprises a sleeve (1) for substantially covering a portionof the body part, in particular the limb, of a user. The sleeve includesan outer surface (3), an inner surface (4), an upper edge (7), a loweredge (8) and two lateral side edges (9, 10). As in the other exemplaryembodiments, in the transverse direction from the first lateral sideedge (9) to the second lateral side edge (10) the sleeve comprises afirst lateral side region (13), a central region (14) and a secondlateral side region (15). The second lateral edge region of the sleeveis provided with either a plurality of eyelets (12; only one eyelet islabelled) in series between the upper and lower edges of the sleeve. Ascan be appreciated from the Figures, in particular FIG. 7, the secondlateral edge region (15) also includes a stiffener (32) that is locatedbetween the eyelets (12) and the second lateral edge (10). The exemplarycompression device further comprises a plurality of strip-shapedmechanical fastening tabs (2), one fastening tab for each eyelet. Thefastening tabs (2) as well as the first lateral side portion (13) isfavorably configured as described above in conjunction with theexemplary embodiment shown in FIGS. 4 and 5. The exemplary device alsoincludes a tongue (5) desirably affixed to the inner surface (4) at thesecond lateral edge region (15) so that the tongue underlies eyelets andextends outwardly from the second lateral edge (10). The tongue isconfigured as described above in conjunction with the exemplaryembodiment shown in FIGS. 4 and 5. The sleeve also includes an elongate,expandable gusset (11) extending substantially lengthwise between theupper and lower edges (7, 8) of the sleeve, in particular the gussetextends from the upper to the lower edges of the sleeve. The gusset isexpandable in at least the transverse direction of the sleeve andincludes a loop (20) of material to the exterior and rising outwardly,which can be better seen in cross-sectional view shown in FIG. 7. It canalso be seen that the expandable gusset (11) comprises two layers, anouter layer of material (18) and an inner layer of material (19), eachsaid material having elasticity in at least the transverse direction. Ascan be appreciated from FIG. 7, the outer layer of the gusset isintegral with the adjacent-lying material of the sleeve which is themain material (30). The inner layer of the gusset being a separate stripof material affixed to the inner surface of the sleeve, so as to providea loop of outer-layer-material (i.e. the loop (20) of the gusset) abovethe inner layer. The loop (20) is visible as an elongate mound or hump.In use, when the device (100) is applied onto the body part, inparticular onto the limb, of a user, tension will be provided andaccordingly the expandable gusset (11) will expand in the transversedirection and the loop can and will flatten.

Gussets may be at least in part integral with adjacent lying sleevematerial or alternatively gussets may be provided as inset into thesleeve (the exemplary embodiment depicted in FIGS. 8 and 9 is an exampleof the latter). When gusset is at least in part integral with adjacentlying sleeve material favorably that adjacent lying sleeve material isthe main material such that the material of loop is the main material.For such cases, it will be appreciated then the loop material willnormally have the same modulus of elasticity and thickness as the mainmaterial. Otherwise, it may be favorable that the product of the modulusof elasticity of the loop material times the thickness of the loopmaterial is at least 90% of the product of the modulus of elasticity ofsaid main material times the thickness of the main material, inparticular the product of the modulus of elasticity of the loop materialtimes the thickness of the loop material is equal to or greater than theproduct of the modulus of elasticity of said main material times thethickness of the main material.

For those embodiments where the expandable gussets includes two layers(e.g. an outer layer of material and an inner layer of material, eachsaid material having elasticity in at least the transverse direction,where the inner layer of material is affixed to the outer layer ofmaterial, so as to provide a loop of outer-layer-material above theinner layer when the gusset is in its non-expanded state, which, in useunder the provision of tension and accordingly expansion of gusset inthe transverse direction, can flatten), favorably the product of themodulus of elasticity of the inner-layer-material times the thickness ofthe inner-layer-material being less than the product of the modulus ofelasticity of the outer-layer-material times the thickness of theouter-layer-material. In one embodiment, the product of the modulus ofelasticity of the inner-layer-material times the thickness of theinner-layer-material is at least a factor of two times, in oneembodiment at least a factor of four times, lower than the product ofthe modulus of elasticity of the outer-layer-material times thethickness of the outer-layer-material. The two-layer gusset may beprovided as an inset into the sleeve or alternatively, the outer layerof the gusset is integral with the adjacent-lying material of the sleevewith the inner layer of the gusset being a separate strip of materialaffixed to the inner surface of the sleeve. For the latter types ofembodiments, i.e outer-layer is integral with the adjacent-lying sleevematerial, in one embodiment that the adjacent-lying sleeve material isthe main material, and once again for such embodiment it will beappreciated that the modulus of elasticity and the of the loop material,i.e. the outer-layer-material in the two-layer expandable gusset, willbe normally equal to the modulus of elasticity and thickness of the mainmaterial. Otherwise as already indicated above, in one embodiment theproduct of the modulus of elasticity of the material of the loop (e.g.the outer-layer-material in two-layer gusset embodiments) times thethickness of the loop material is favorably at least 90% of the productof the modulus of elasticity of the main material times the thickness ofthe main material, in particular the product of the modulus ofelasticity of the material of the loop times the thickness of the loopmaterial is equal to or greater than the product of the modulus ofelasticity of said main material times the thickness of the mainmaterial.

Although not shown in an illustration, it will be recognized that whenthe exemplary compression device depicted in FIGS. 6 and 7 is put to usecovering the body part, in particular the limb, of a user (e.g. thelower leg including the calf of a user), the fastening tabs (2) will bepassed through the eyelets (12), turned back and fastened ontothemselves. The first lateral edge (9) will be thus drawn towardseyelets (12) and accordingly towards the second lateral edge (10) of thesleeve (1). Favorably the two lateral edges of the sleeve will notoverlap, but will define an opening behind which the tongue (5) will becentrally positioned. Moreover in applying the compression devicedepicted in FIGS. 6 and 7, the sleeve (1) is positioned about the bodypart, in particular the limb, of the user, each of fastening tabs (2) isthreaded through its opposing eyelet (12), turned back on itself andpulled such the first lateral side edge (9) of the sleeve is drawntowards the eyelets (12) so that the sleeve is tightened about the bodypart, in particular the limb, of the user, wherein the tab is pulleduntil the loop of the expandable gusset fully flattens out. Once theloop disappears, the fastening tabs are fastened so that the sleeve (andcorrespondingly the compression device) is restrained about the bodypart, in particular the limb, of the user.

Gussets desirably have in their non-expanded state a width relative tothe transverse direction of the sleeve of at least 0.1 cm, moredesirably at least 0.5 cm. Gussets desirably have in their non-expandedstate a width relative to the transverse direction of the sleeve of atmost 4 cm, more desirably at most 3 cm. In one embodiment, gussets havein their expanded state at the point where the loop just fully flattensout a width relative to the transverse direction of the sleeve of atleast 1 cm. In one embodiment, gussets have in their expanded state atthe point where the loop just fully flattens out a width relative to thetransverse direction of the sleeve is at most 8 cm, in particular atmost 6 cm.

Gussets may be provided anywhere in the sleeve between the fasteningtabs and eyelets (or rings, for those embodiments including ringsinstead of eyelets). For ease in viewing loop-indicating configurationof the gusset while the device is being applied, suitably gussets may beprovided in the central portion of the sleeve or in the second lateralside portion, more suitably in the central portion of the sleeve nearthe eyelets (or rings, if applicable) or in the second lateral sideportion near or adjacent to the eyelets (or rings, if applicable)towards the central portion.

Returning to the exemplary embodiment depicted in FIGS. 6 and 7, it canbe seen that the gusset is in the central portion (14) of the sleevewith the gusset being positioned near the eyelets (12) and thus distantto the fastening tabs (2) attached to the first lateral edge region (13)of the sleeve. Although not shown in an illustration, it will beappreciated that when this exemplary compression device (100) is in useon the body part, in particular the limb, of the user, the sleeve (1)will be disposed about a central axis (A), said central axis lying in aplane (P), and the gusset will extend along a third axis (G), whereinrelative to a projection of this third axis (G) onto said plane (P)containing the central axis (A), the third axis (G) will be in parallelor essentially parallel alignment with the central axis (A). Inalternative embodiments, gussets can be configured and arranged suchthat the aforesaid third axis (G) is inclined forming an acute angle (β)up to 25° inclusive relative to the central axis.

The exemplary compression device shown in FIGS. 8 and 9 is an example ofan embodiment where the expandable gusset (11) is arranged such thatwhen the compression device (100) is in use on the body part, inparticular the limb, of the user, the gusset extends along a third axis(G), wherein relative to a projection of the third axis (G) onto saidplane (P) containing the central axis (A), the third axis (G) isinclined forming an acute angle (β) relative to the central axis (A). Inparticular, the exemplary compression device shown in FIGS. 8 and 9includes a sleeve (1) having instead of eyelets, a plurality of rings(16) in series between the upper and lower edges (7, 8) of the sleeve.Each ring is favorably fixedly attached by a strap (17) extendingbetween the sleeve (1) and the ring (16). The rings of this exemplarydevice are positioned along the second lateral edge (10) of the sleeveand spaced apart from said edge and away from the second lateral edgeregion (15), in particular the lateral edge (39) of each ring which isnear the second lateral edge (10) of the sleeve is spaced apart from thesecond lateral edge of the sleeve. In one embodiment, the spacingcorresponds to a distance of at most 4 cm, more favorably at most 3 cm.Alternatively, rings may be positioned adjacent to the second lateraledge (but still away from the second lateral edge region (15)), inparticular, the lateral edge (39) of each ring which is near the secondlateral edge (10) of the sleeve may be positioned adjacent to the secondlateral edge of the sleeve. From FIG. 9, it can be seen in thisexemplary embodiment that the ring-straps are attached to the secondlateral edge region (15) of the sleeve and the region (15) of the sleeveis provided with a stiffener (32). The exemplary embodiment includesfastening tabs (2) and a tongue (5), both elements configured andarranged as previously described above. In regard to the expandablegusset (11), it can be recognized from FIG. 9 that in this exemplaryembodiment the gusset is provided as an inset provided in the sleeve, inparticular in the central region (14) thereof. Moreover referring to theillustration of FIG. 9, it can be seen that the sleeve is made of twoindividual parts (1 a and 1 b) and that the gusset (11) comprises anouter layer of material (18) and inner layer of material (19), whereinthe inner layer of material is affixed to the inner surface of the outerlayer of material and configured and arranged so as to provide a loop(20) of outer-layer-material above the inner layer, and wherein thegusset is then affixed to inner surface (4) of the each of two sleeveparts (1 a, 1 b), thus bridging the two sleeve-parts to provide acomplete sleeve with the loop (20) facing outwardly. As can beappreciated from the FIG. 9, each of the two sleeve parts (1 a, 1 b)includes main material (30) so that the central portion of the sleevecomprises for the most part main material, i.e. the central portion ofthe sleeve with the exception of the inset-gusset is made of the mainmaterial.

Referring to the illustration of FIG. 8, it can be seen that the gussetof this exemplary embodiment is inclined relative to e.g. the secondlateral edge (10). Moreover, reference is made to FIG. 10a showing aperspective, front view of the exemplary compression device (100)depicted in FIGS. 8 and 9, in use on the lower leg of a user, it can berecognized that the sleeve (1) is disposed about a central axis (A) andthe gusset (11) extends lengthwise along a third axis (G). Makingreference to FIG. 10b showing a projection of this axis (G) on the plane(P) containing the central axis (A) it can be appreciated that relativeto a projection of the third axis (G) onto said plane (P) containing thecentral axis (A), the third axis (G) is inclined forming an acute angle(β) of about 12° relative to the central axis. Returning to FIG. 10a ,one can also see that when the compression device (100) is in use, thegusset (11) will expand in the transverse direction and the loop willflatten. As suggested in FIG. 10a , when the device is properly appliedthe gusset will be expanded such that the loop is fully flattened out,i.e. it disappears. It can also be appreciated from FIGS. 10a and 10b ,that when the exemplary device is in use on the limb (e.g. the lowerleg) of the user, the plurality of rings extends along a second axis(R), wherein relative to a projection of the second axis (R) onto saidplane (P) containing the central axis (A), this second axis (R) is inparallel alignment or essentially parallel alignment relative to thecentral axis.

The exemplary compression device shown in FIGS. 11 and 12 is a variantof the exemplary embodiment shown in FIGS. 8 and 9 and differing in twoaspects: The first being that the gusset (11) is not provided an inset,but rather the outer layer (18) of the gusset (11) is integral with theadjacent-lying material of the sleeve (1), in this particular embodimentwith the main material of the sleeve, with the inner layer (19) of thegusset being a separate strip of material affixed to the inner surface(4) of the sleeve. Secondly the gusset (11) extends lengthwise such thatwhen the compression device (100) is in use on the body part, inparticular on the limb, of the user, the gusset extends along a thirdaxis (G), wherein relative to a projection of the third axis (G) ontosaid plane (P) containing the central axis (A), the third axis (G) isparallel or essentially parallel to the central axis.

Although not specifically shown in the exemplary embodiments depictedherein, compression devices described herein may be configured toinclude other structural elements, for example a foot portion extendingfrom the sleeve, in particular extending from an appropriate portion ofthe lower edge of the sleeve. Such a foot portion may be configured andarranged in the form of a stir-up or alternatively such as foot portionmay be configured to provide a more extensive covering of the foot.Moreover the sleeve and such a foot portion may be configured andarranged so as to provide a boot-like compression device, either closedor opened toed and/or either closed or opened heeled. Such a foot partmay be provided integrally with the sleeve or alternatively as aseparate component that can be attached to the sleeve by an appropriatefastening means, such as buttons, mechanical fasteners and the like.Compression devices may also include bladders or gel inserts tofacilitate modification of circumferential size. In this regard,sleeves, for example, could be provided with double walls or interiorpockets for such inserts so that such insert(s) may be inserted and/orremoved as needed or desired.

The following examples further illustrate the practice of the presentinvention. The examples are not intended to limit the invention, whichis defined in the appended claims.

Test Methods

Test Methodology for Elongation and Recovered Elongation

Elongation and Recovered Elongation were determined through measurementsbased on BS EN 14704-1:2005 “Determination of the elasticity of fabrics,—Part 1: Strip tests”: Method A, Knitted Fabrics (see inter aliasections 8.2.2 & 9.2.1) with the following variations and/or conditionsto given method:

(i) strip test specimens were cut with their length parallel todirection to be measured, i.e. strips were cut so that the length ofspecimen is parallel either to the direction of the material that wouldbe in the transverse/circumferential direction of the sleeve (fordeterminations in said transverse direction) or to the direction of thematerial that would be in the longitudinal direction of the sleeve (fordeterminations in said longitudinal direction)

(ii) specimen size was 250 mm in length and 5 cm wide (see 8.2.2.1.1);

(ii) gauge length was set at 70 mm (see 9.2.1.1);

(iii) extension rate was set at 500 mm/min (as given in section9.2.1.2);

(iv) required cycling limits were set to said gauge length and a fixedload of 10 N per cm width (which corresponds to 50 N for given specimenwidth) (see subsection 9.2.1.3);

(vi) on the first cycle as well as on final (i.e. fifth) cycle, thetesting machine was set to hold at 10 N per cm width for 1 minute (seeNOTE 2 of 9.3);

(vii) the recovery period was 30 min (see NOTE 3 of 9.3);

(vii) test specimens were preconditioned for 24 hours at 50% RH and 20°C.; and

(viii) the number of test specimens were three, where then thearithmetic mean is reported;

and with the following results: (a) percent elongation (S) is[(extension (mm) at maximum force on the final cycle—initiallength)/initial length]×100; (b) percent recovered elongation (D) is(100—un-recovered elongation in percentage) and percent un-recoveredelongation (C) is [(Q-P)/P]×100 where Q is the distance between appliedreference marks (mm) after specified hold and recovery periods followingthe 5^(th) cycle and P is the initial distance between reference marks(mm); (c) percent elongation rise due to time is [(elongation on thefinal cycle, after specified holding period—elongation on the finalcycle, prior specified holding period (i.e. S))/elongation on the finalcycle, prior specified holding period]×100.

Test Methodology for Tension

Tension was determined through measurements based on BS EN 14704-1:2005“Determination of the elasticity of fabrics, —Part 1: Strip tests”:Method A, Knitted Fabrics (see inter alia sections 8.2.2 & 9.2.1) withthe following variations and/or conditions to given method:

-   -   (i) strip test specimens were cut with their length parallel to        direction to be measured, i.e. strips were cut so that the        length of specimen is parallel either to the direction of the        material that would be in the transverse/circumferential        direction of the sleeve (for determinations in said transverse        direction) or to the direction of the material that would be in        the longitudinal direction of the sleeve (for determinations in        said longitudinal direction)

(ii) specimen size was 100 mm in length and 2.5 cm wide (see 8.2.2.1.1);

(ii) gauge length was set at 70 mm (see 9.2.1.1);

(iii) extension rate was set at 500 mm/min (as given in section9.2.1.2);

(iv) required cycling limits were set to said gauge length and a fixedelongation of 30% (see subsection 9.2.1.3);

(v) during cycling and elongation up to fixed elongation of 30%, theforces measured at 10%, 15%, 20% and 25% elongation were recorded inaddition to force measured at 30% elongation;

(vi) on the final (i.e. fifth) cycle, the testing machine was held atthe maximum elongation (i.e. 30% elongation) for 1 minute (see NOTE 2 of9.3);

(vii) test specimens were preconditioned for 24 hours at 50% RH and 20°C.; and

(viii) the number of test specimens were three, where then thearithmetic mean is reported; and with the following results: (a) tensionat 30% elongation is the recorded maximum force at 30% elongation fromthe final cycle divided by the width size (i.e. 2.5 cm) of the specimen;(b) tensions at 10%, 15%, 20% and 25% elongation were the forcesrecorded at 10%, 15%, 20% and 25% elongation during the final cycledivided by the width size (i.e. 2.5 cm) of the specimen; and (c)difference quotient of tension from a first percent elongation to asecond percent elongation is [(tension at the second percentelongation—tension at the first percent elongation)/(second elongationin percentage-first elongation in percentage)].

Test Methodology for Water Vapor Transmission Rate

The water vapor transmission rate of fabrics was determined according totest method DIN EN ISO 15106-part 1:2005 “Determination of Water VapourTransmission Rate—Part 1 Humidity Detection Densor Method” with thefollowing parameters, conditions and/or variations to given method:

-   (i) 38° C.; water vapor difference 90%; relative humidity upper    chamber 10%, relative humidity lower chamber 100% (see Table 1;    parameter set 2 in Section 8);-   (ii) a reference specimen Core Tex, 5000 g/(m²·24 h), lot 071808;    16.11.2009;-   (iii) circular diffusion area having a diameter of 10 mm;-   (iv) number of test specimens were three (specimens were die-cut    with a die having a cutting circle of 30 mm diameter, the aluminum    barrier film was cut with a die having a cutting circle of 10 mm    diameter; sample cards from MRS Seitter GmbH. Version: MRS 0225; lot    no.: 100604 were used);-   (v) test specimens were preconditioned for 24 hours at 50% RH and    23° C. prior to testing; and-   (vi) Easyperm WVPT 650M from Gintronic AG, Ruti, Switzerland,    CH-8630 was used as measurement equipment; and with water vapor    transmission rate reported in g/(m²·24h).    Test Methodology for Bending Length and Flexural Rigidity

The bending length and flexural rigidity of fabrics were determinedaccording to test method ISO 9073-7 1^(st) Edition 1995-12-15“Textiles—Test methods for nonwovens Part 7: Determination of bendinglength” § Standard Test Method for Stiffness of Fabrics” with thefollowing parameters and conditions:

-   (i) Specimen was 1 inch×8 inch (i.e. 25.4 mm×203.2 mm);-   (ii) Specimens were pre-conditioned for 24 hours and tested at    21° C. and 65% RH;-   (iii) Three specimens for each testing (machine and cross) direction    was tested (MD corresponds to the longitudinal direction of the    sleeve, while CD corresponds the transverse direction of the    sleeve), where average value is reported;-   (iv) Tests were performed using a M003B Shirley Stiffness Tester;    and with bending length (C) in units of cm for each testing    direction being equal to length of overhang divided by two and    flexural rigidity (G), per unit width, in units of milliNewton    centimeters being calculated using the equation G=m×C³×10⁻³ where m    is the mass of the test piece per unit area in g/m² and C is bending    length in cm.    Materials:

M1: Warp knitted spacer marketed by Gehring Textiles Inc., Garden City,N.Y. 11530, USA under the trade designation SHR 700/3 D3 D/O 7208810,having the following characteristics:

-   -   100% polyester with a basis weight of 288 g/m² and a thickness        of 2.3 mm;    -   outer layers made of multifilament yarns having a yarn diameter        of approximately 200 μm and a single filament diameter of        approximately 15 μm and a spacer layer made of monofilament yarn        having a diameter of approximately 65 μm; and    -   a knitted structure as shown in scanning electron and light        microscopy images in FIG. 15 a to e.

In use, side 1 (i.e. that side shown in FIG. 15a ) was used towards theinterior of the device and side 2 (i.e. that side shown in FIG. 15b & c)was used towards the exterior of the device.

M2: Warp knitted spacer marketed by Müller Textil, 51674 Wiehl, Germanyunder the trade designation 3 Mesh 5992 having the followingcharacteristics:

100% polyester with a basis weight of 380 g/m² and a thickness ofapproximately 2.6 mm;

outer layers made of multifilament yarns with a spacer layer made of amonofilament yarn of approximately 65 μm diameter;

the multifilament yarns of the first and second outer are different, forone side (side 1) the yarn diameter is approximately 400 μm with singlefilaments having diameters in the range of about 10 μm to about 22 μm,the majority in the range of about 16 μm to about 19 μm and for theother side (side 2) the yarn diameter is approximately 250 μm withsingle filaments of irregular shape having diameters in the range ofabout 10 μm to about 22 μm, the majority in the range of about 16 μm toabout 19 μm; and

a knitted structure as shown in scanning electron and light microscopyimages in FIG. 16 a to d.

In use, side 1 (i.e. that side shown in FIG. 15a ) was used towards theinterior of the device and side 2 (i.e. that side shown in FIG. 16b )was used towards the exterior of the device.

CM1: Fabric of the compression product marketed by Circaid MedicalProducts, Inc. San Diego, Calif. 92123, USA under the trade designationJUXTACURES (product purchased in 2012);

CM2: Fabric of compression product marketed by FarrowMed, LLC, Texas77803, USA under the trade designation FARROWWRAP Trim-to-Fit strong(product purchased in 2012):

CM3: Fabric used in the wrist-splint product marketed by 3M Futuro underthe trade designation Reversible Splint Wrist (“Handgelenkschiene”product number 47855). Laminate of polyester knitted fabric/polyurethanefoam/polyester knitted fabric from Rubberlite, Huntington W. Va. 25703,USA with a thickness of 3.1 mm and a weight of 600 g/m²:RP-M-767//0.075″ Rubberlite S0702 Foam//RF-M-2877. The polyester fabricsRP-M-767 and RF-M-2877 are manufactured by Green Textiles, Spartanburg,S.C. 29301-4929, USA.

Material Properties Testing Results

TABLE 1 Determination of Elongation, Elongation Rise and RecoveredElongation in Transverse/Circumferential Direction Elongation (%) atElongation (%) at 10N per cm width Recovered 10N per cm width At end of5^(th) cycle Elongation Elongation Material At end of 5^(th) cycle &after 1 min hold Rise (%) (%) M1- transverse 18.3 18.9 3.3 95 M2 -transverse 21.4 21.8 1.9 99 CM1 - transverse 40.7 44.3 8.8 98 CM2-transverse 71.6 75.6 5.6 95 CM3 - transverse 32.7 34.0 4.0 98

TABLE 2 Determination of Elongation, Elongation Rise and RecoveredElongation in Longitudinal Direction Elongation (%) at Elongation (%) at10N per cm width Recovered 10N per cm width At end of 5^(th) cycleElongation Elongation Material At end of 5^(th) cycle & after 1 min holdRise (%) (%) M1- long 29.4 30.3 3.1 94 M2 - long 34.4 34.8 1.2 98 CM1 -long 40.9 43.6 6.6 90 CM2- long 76.9 79.9 3.9 97 CM3 - long 60.1 63.45.5 93

TABLE 3 Determination of Tension in Transverse/Circumferential DirectionTension after Tension hold (N per (N per cm width) cm width) 15% 20% 25%30% 30% Elonga- Elon- Elon- Elon- Elon- tion after Material gationgation gation gation 1 min hold M1 - transverse 0.3 2.8 11.9 31.2 24.3M2 - transverse 0.7 3.3 11.4 34.1 26.1 CM1 transverse 2.7 4.3 6.3 9.16.9 CM2 - transverse 1.3 1.9 2.5 3.3 2.9 CM3 - transverse 1.6 2.8 4.67.5 6.1

The results tension versus percent elongation determined in the finalcycle are plotted in FIG. 17. The following table provides thedifference quotients from a first elongation to a second elongation.

TABLE 4 Difference Quotients of Tension in Transverse/CircumferentialDirection versus % Elongation Difference Quotient (Δ N per cm width/Δ %elongation) 15%. to. 20% 20%. to 25% 25%. to 30% Material ElongationElongation Elongation M1 - transverse 0.49 1.83 3.85 M2 - transverse0.53 1.62 4.53 CM1 transverse 0.32 0.41 0.55 CM2 - transverse 0.12 0.130.15 CM3 - transverse 0.25 0.35 0.59

TABLE 5 Determination of Tension in Longitudinal Direction Tension afterTension hold (N per (N per cm width) cm width) 15% 20% 25% 30% 30%Elonga- Elon- Elon- Elon- Elon- tion after Material gation gation gationgation 1 min hold M1 - long 0.7 2.0 4.7 10.9 8.6 M2 - long 0.7 1.4 2.86.7 5.4 CM1 long 2.5 4.7 7.9 12.9 9.3 CM2 - long 1.4 2.4 3.9 6.0 4.7CM3 - long 1.1 1.9 2.9 4.3 3.5

TABLE 6 Tension Ratio - Transverse/Circumferential versus LongitudinalDirection and vice versa Tension Ratio Tension RatioTransverse/Longitudinal Longitudinal/Transverse 30% 30% elonga- 30% 30%elonga- Elon- tion after Elon- tion after Material gation 1 min holdgation 1 min hold M1 2.9 2.8 0.3 0.35 M2 5.1 4.8 0.2 0.2 CM1 0.7 0.7 1.41.3 CM2 0.5 0.6 1.8 1.6 CM3 1.8 1.8 0.6 0.6

TABLE 7 Determination of Water Vapor Transmission Rate - WVTR (g/(m² ·24 h)) Material from inside out¹ from outside in² M1 2571 2601 M2 24982464 CM1 1874 1569 CM2 2187 2171 CM3 1710 1850 ¹Here duringWVTR-testing, the side of the material that would be on the interior ofa compression device was placed towards the water vapor feed ²Hereduring WVTR-testing, the side of the material that would be on theexterior of a compression device was placed towards the water vapor feed

TABLE 8 Determination of Bending Length and Flexural rigidity BendingLength Flexural rigidity Material (cm) (mN · cm) M1, (CD, transverse)3.5 12.3 M1, (MD; longitudinal direction) 4.4 24.5 M2, (CD, transversedirection) 3.9 22.5 M2, (MD; longitudinal direction) 3.5 16.3Tests with Compression DevicesTest Methodology Using an Artificial Leg

A non-compressible artificial leg made out of plastic with a length of35 cm between ankle (center) and lower end of the knee, a circumferenceof 24 cm just above the ankle and a circumference of 35.5 cm at the calfarea (at the location of the measurements) was used to test compressiondevices. An inflatable air bladder placed between artificial leg andcompression device was used to simulate leg volume expansion, forexample the typical volume expansion when a person moves from asupine/rest position to a standing position. The artificial leg wasfirst covered with a 35 cm long piece of white knitted polyesterstockinet (3M Stockinet 7.6 cm×22.8 m (MS03; 70-2004-7301-8)) tofacilitate uniform expansion and contraction of the bladder duringexpansion and evacuation. The bladder was fixed on the stockinet (seebelow) so that during test it was located between the stockinet andcompression device. The circular pouch having a diameter of 110 mm thatcomes together with a sensor in a Kikuhime sub-bandage pressureequipment, received from TT MediTrade ApS, Søleddet 16, 4180 Sorø,Denmark was fitted to serve as the inflatable bladder. The bladder atits edge was fixed with two 4 cm long stripes of 3M Micropore tape onthe stockinet on the front side (tibia) of the artificial leg andpositioned so that it was centered where the circumference of theartificial leg is 355 mm. A Pico Press pressure sensor from MicroLabElettronica, Italy, of approx. 50 mm diameter was fixed the same way onthe stockinet at the calf region at the same leg height like theinflatable bladder. The tubes of sensor and bladder were led to the kneezone of the artificial leg and were secured with 3M Micropore tape, too.Via a valve the inflatable bladder was connected with bellows. Thesensor was connected with a Pico Press pressure measurement unit fromMicroLab Elettronica Sas, Roncaglia di Ponte San Nicolò (PD), Italy.

For the compression devices tested, two pen-marks were made on the outersurface on the device such that when the device is on the artificial legthe two marks are at the height corresponding to a circumferential linerunning through the centers of the bladder and sensor. For example inrelation to a tested compression device having a design like that shownin FIG. 1, described in more detail below making reference to FIGS. 13and 14, in this position the bladder is centered at a height in linewith marks M′ and M″ and line W_(M) in FIG. 13. The distance between themarks was at least 12 cm (in non-expanded state) and both marks wereplaced so that they were on the main compression material with only maincompression material located there between. Moreover the marks wereplaced so that they were not on a closure system, a stiffener or anyother subsidiary element to the main material.

All materials and equipment were exposed to ambient conditions (23°C.+−2° C.; 50%+−10% r.h.) within 24 hours prior to and duringmeasurements.

Pressure at Supine/Rest Position

The inflatable bladder was evacuated and empty, and the compressiondevice to be tested was applied to the artificial leg and was thenclosed and tightened, such that a pressure of approximately 42 mmHg(+/−3 mmHg) was achieved (as measured with the Pico Press device).

The exact pressure was reported and designated as “pressure at rest”.The artificial leg was positioned such that its own weight did notinfluence the pressure distribution at the locations of interest (i.e.for instance upright position and not laying).

Standing Pressure

Thereafter the circumference around the compression device at theposition where the sensor and the evacuated/empty bladder are attachedwas measured with a measuring tape. Then, the valve of the bladder wasopened, the bladder was filled with air to such an extent that thecircumference was increased by 1 cm (+−0.1 cm), and finally the valve ofthe bladder was closed. Again, the pressure was measured and recorded asthe “standing pressure”.

Stretched Reference Distance

The shortest transverse/circumferential distance between the two markson the outer surface of the tested compression device was measured witha measurement tape with an accuracy of +−1 mm and was designated as“stretched-reference-distance”.

After this, the valve was opened and the bladder was evacuated. Then,the procedure was repeated within 10 minutes. The above mentioned values(pressure at rest, standing pressure and stretched-reference-distance)were measured again and were recorded. The reported values are anaverage of the two measurements.

Non-stretched Reference Distance

Thereafter the compression device was taken off the artificial leg andafter 30 minutes waiting time, the shortest transverse/circumferentialdistance between the marks was measured again and recorded as“non-stretched-reference-distance”.

The “pressure difference” is the difference between “standing pressure”and “pressure at rest” and is a measure for the stretch resistance ofthe device. The percent “device-stretch” value is(stretched-reference-distance value minus thenon-stretched-reference-distance) divided by non-stretchedreference-distance times 100. (Note: the shortest distance between themarks M′ and M″ in the flat, laid opened device is a straight line. Whenthe device is applied, the line (which could be marked on the device),along which the shortest distance between same marks is then measured,may not exactly congruent with the above mentioned straight line. Whilethis could be considered as to cause a certain, but small amount ofinaccuracy of the calculated percent device-stretch, this is negligiblesince all the tested devices were measured that same way.

Tested Compression Devices:

S1: Compression Device according to prototype design shown in FIGS. 13and 14 and described below using material M1 as main material.

-   -   CS1: Compression product marketed by Circaid Medical Products,        Inc. San Diego, Calif. 92123, USA under the trade designation        JUXTACURES (product purchased in 2012);    -   The device was customized according to the manufacturer's        instructions to fit the used artificial leg. Referring to Figure        tin WO 2011/066237 the spine portion was attached to the body        portion so that the spine curve was positioned such that its        upper edge was located at a position of 36 cm and its lower edge        at a position of 24 cm and excess material of the body portion        was thereafter trimmed away.    -   CS2: Compression product marketed by FarrowMed, LLC, Texas        77803, USA under the trade designation FARROWWRAP Trim-to-Fit        strong (medium size) (product purchased in 2012): Referring to        US 2005/0209545, this product consisting of a series of        overlapping straps (10 cm in height) fixed in their middle along        a central band. When applied, the straps overlap with approx.        50% in longitudinal direction resulting in two layers of        material at the overlapping portions of the straps.        Additionally, due to overlapping and fixing of the straps around        the circumference there is a further material overlap and        accordingly in some portions have three and even four layers of        overlap. For the testing described below, a four strap product        was used, the straps having an overall length in the transverse        direction of 46 cm, 45 cm, 41 cm and 32 cm, respectively (the        shortest strap positioned near the ankle and the longest near        the knee):    -   CS3: Reference compression device according to prototype design        shown in FIGS. 13 and 14 and described below using material CM3        as main material.        Prototype Design for S1 and Reference CS3

S1 and CS3 were made according to the same design as shown in FIGS. 13and 14, wherein the only difference was the main material of the twoprototypes. In other words for S1 the main material was M1 and for CS3the main material was CM3, while the closure system and all the otherelements were the same. Referring to FIGS. 13 and 14, the followingdimensions and materials were used:

W_(o) = 70 mm R₂ = 500 mm D₈ = 57 mm W_(H) = 220 mm D₁ = 22 mm D₉ = 35mm R_(o) = 150 mm D₂ = 50 mm D₁₀ = 17 mm R_(H) = 500 mm D₃ = 50 mm D₁₁ =D₆ + D₇ = 18 mm H = 355 mm D₄ = 22 mm D₁₂ = 12 mm R₆ = R₅ = R₄ = R₃ = 20mm D₅ = 15 mm D₁₃ = 100 mm U = 350 mm D₆ = 8 mm D₁₄ = 70 mm R₁ = 150 mmD₇ = 10 mm D₁₅ = 90 mm T = 140 mm D₁₆ = 35 mm

Sleeve (1 in FIGS. 13 and 14) was made of material M1 or CM3, asdescribed above.

Tongue (5 in FIGS. 13 and 14) was made from a foam-comprising laminatematerial obtained from Rubberlite, Huntington, W. Va. 25703, USAmarketed under the trade designation VISCO

TRI-VISCO (PU foam 3921130000) made of the following four layers (fromthe interior to the exterior): a) Black Polyester Jersey Fabric fromGreen Textile Association marketed under trade designation StyleP-J-0035 401; b) polyurethane foam from Rubberlite marketed under thetrade designation HYPUR-CEL T0812 (1.6 mm thick); c) polyurethane foamfrom Rubberlite marketed under the trade designation VISCO-CEL V0575(2.4 mm thick); and d) Silver Polyester Jersey Fabric from Green TextileAssociation marketed under the trade designation SR-4816; said layersbeing laminated with a urethane curing hot-melt. The tongue was attachedalong one of its lateral edge to the inner surface of the sleeve at thesecond lateral side region by sewing.

Stiffener (32 in FIGS. 13 and 14) was a 1.6 mm thick thermoplastic ductmaterial from 3M marketed under the trade designation SCOTCHCAST 72362;the material covering the stiffener (32 a in FIGS. 13 and 14) is asuede-like, 100% cotton fabric.

Fastening strips (2 in FIGS. 13 and 14) were made by sewing anappropriate strip of a loop material from Velcro USA Incorporatedmarketed under the trade designation VELCRO Loop 1000 (22 and 23 inFIGS. 13 and 14) together with an appropriate strip a hook material fromVelcro USA marketed under the trade designation VELCRO Hook 88 (24 inFIGS. 13 and 14). The fastening strips were attached onto the sleeve inthe first lateral side region by sewing.

Oval rings (16 in FIGS. 13 and 14) were made of stainless steel; ringwire of 2.5 mm diameter, 6.9 mm inner width; 52 mm inner height, 3 mminner radius of top and bottom, as illustrated in

FIGS. 13 and 14 the rings were attached via straps (17 in FIGS. 13 and14)) made of the aforesaid loop material by sewing onto an elongatestrip (17 a in FIGS. 13 and 14) of 100% polyester material, the elongatestrip then attached by sewing onto the outer surface of the sleeve atthe second lateral side region so the ring straps were located above andalong the stiffener.

Yarn: 40-PermaCore, A&E: American & Efird LLC, Mt. Holly, N.C., USA forsewing the relevant components together.

When the devices S1 and CS3 were applied and closed but not yettightened on the artificial leg, the width of the main material incircumference direction along the line marked W_(x) in FIG. 13 wasapproximately 60% compared to the overall circumference of the device atthe same height. As indicated above, when testing with the artificialleg, the sensor and bladder are positioned at the height correspondingto M′, M″ and W_(M). It will be appreciated that the regions of thesleeve (i.e. the first and second lateral edge regions) where thefastening strips, ring straps, stiffener and tongue were fixedlyattached are non-stretchable or essentially non-stretchable. When thedevice was not in use, the central region of the sleeve, i.e. thatregion between the longitudinal, interior seams (29 in FIG. 14)connecting the fastening tabs to the sleeve and the seam (31 in FIG. 14)connecting the tongue and ring straps to the sleeve, had an area thatwas about 54% of the total area of the sleeve. The percent areas of thefirst and second lateral side regions were about 33% and 13%,respectively.

Results of Testing on Artificial Leg:

TABLE 9 Pressure measurements of tested devices Pressure at rest¹Standing pressure² Pressure difference Device (mmHg) (mmHg) (mmHg) S1 4375 32 CS1 45 51 6 CS2 34 48 4 CS3 41 49 8 ¹inflatable bladderempty/evacuated ²inflatable bladder inflated so that the circumferenceis increased 1 cm

TABLE 10 Stretch and non-stretch measurements (between M′ and M″) oftested devices Non-stretched- Stretched Device- reference-distancereference-distance stretch Device (cm) (cm) (%) S1 18.5 21.0 14 CS1 23.026.0 13 CS2 25.0 29.0 16 CS3 16.5 20.8 26

Referring to the measured pressure, it can be seen that compressiondevice S1 exhibits a significantly higher pressure difference than theother tested devices. In particular the pressure difference value for S1is four times greater than that measured for the reference device CS3.Considering that S1 and CS3 differ only in the main material, i.e. M1versus the reference material CM3, this demonstrates that thecompression material M1 is particularly advantageous for use incompression therapy. Moreover, the results of the testing demonstratesthat the use of such a main material having a low percent elongation at10 N per cm width in conjunction with a high difference quotient oftension from 20% elongation to 25% elongation allows for advantageousstretch resistance and thus desirably high compression pressures foreffective therapy.

A direct comparison between S1 to CS1 is somewhat complicated by thefact that the constructional designs of the compression devices aredifferent. Moreover in CS1 at that height where the sensor and bladderwere located, 14% of the circumference of the leg is covered withnon-stretchable material, i.e. the non-stretchable closure system, whilethe remaining 86% is covered with the compression material of CS1, whilethe main compression material of S1 covers 60% at the same height (i.e.at the height corresponding to line W_(x) in FIG. 13). So if CS1 hadonly covered 60% instead of 86% with the compression material of CS1 thepressure difference would be correspondingly roughly 1.5 times higher,i.e. around 9 mmHg. This value is significantly less than (about 3.5times less) the pressure difference of S1.

Similarly a direct comparison between S1 to CS2 is somewhat complicatedby the fact that the constructional designs of the compression devicesare different, in particular the fact that at the height where thebladder and sensor were located, the straps of CS2 overlap providing atleast two layers (again the ends of the straps form a three or fourlayer overlap). Moreover in CS2 at that height where the sensor andbladder were located, at least 2 layers of compression material of CS2cover 86% of the circumference of the leg (i.e. the non-stretchablehook/loop closure system represents 14% of the circumference). If CS2had covered in a single layer only 60% of the circumference of the leg,the pressure difference would be roughly the same or even slightlysmaller, i.e. around 3 mmHg, i.e. 1.5 times higher due tocircumferential difference but 2 times lower due to coverage by onelayer instead of two layers.

Various modifications and alterations to this invention will becomeapparent to those skilled in the art without departing from the scopeand spirit of this invention. It should be understood that thisinvention is not intended to be unduly limited by the illustrativeembodiments and examples set forth herein and that such examples andembodiments are presented by way of example only with the scope of theinvention intended to be limited only by the claims set forth herein asfollows.

The invention claimed is:
 1. A compression device for applyingcompression to a body part of a user comprising a sleeve forsubstantially covering a portion of the body part of a user, wherein thesleeve has an outer surface, an inner surface, an upper edge, a loweredge and two lateral side edges, wherein in the transverse directionfrom the first lateral side edge to the second lateral side edge thesleeve comprises a first lateral side region, a central region and asecond lateral side region, and wherein at least the central region ofthe sleeve comprises a main material having elasticity in at least thetransverse direction of the sleeve, a maximum elongation in saidtransverse direction from 5% up to and including 30% under a load of 10N per cm width, a difference quotient of tension in transverse directionfrom 20% elongation to 25% elongation equal to or greater than 0.6 N percm width per percent elongation; wherein the device further comprises areleasable closure system, said closure system being configured andarranged relative to the sleeve, such that, in use, upon closure of theclosure system the sleeve is restrained and tightened about the bodypart of the user.
 2. The compression device according to claim 1,wherein the closure system comprises a mechanical fastening closuresystem, and wherein the second lateral side region of the sleeve isprovided with either a plurality of eyelets or a plurality of rings inseries between the upper and lower edges of the sleeve, wherein thecompression device further comprises a plurality of strip-shapedmechanical fastening tabs, wherein a single tab is provided for eacheyelet or ring, as applicable, each tab comprising a proximal endportion and a distal end portion being connected by an inner tabportion, wherein said proximal end portion is releasably or fixedlyattached to the first lateral side region of the sleeve such that thetab is located opposite to an eyelet or ring, as applicable, and extendsin substantially the transverse direction of the sleeve with the distalend portion positioned away from the central portion of the sleeve,wherein each tab has a inner major surface located towards the outersurface of the sleeve and a outer major surface located away from theouter surface of the sleeve, wherein the outer major surface at thedistal end portion of the tab comprises one part of a mechanicalfastening system and said outer major surface at the proximal endportion of the tab comprise the complementary part of the mechanicalfastening system; and wherein the tabs and eyelets or rings, asapplicable, are configured and arranged such that, in use, the tabs arepassed through the eyelets or rings, as applicable, then turned back onthemselves such that the first lateral side edge of the sleeve is drawntowards the eyelets or rings, as applicable, and then fastened so thatthe sleeve is tightened and restrained about the body part of the user.3. The compression device according to claim 2, wherein the sleeve isprovided with a plurality of rings, and wherein each ring is releasablyor fixedly attached by a strap extending between the sleeve and the ringin substantially the transverse direction of the sleeve, and wherein atleast a portion of said strap is expandable in at least the transversedirection, said expandable portion comprising a material havingelasticity in at least the transverse direction and being configured andarranged, such that when the expandable portion is in a non-expandedstate there is exteriorly a loop of material rising outwardly and when,in use under the provision of tension in the transverse direction of thesleeve, the expandable portion expands in the transverse direction andthe loop flattens.
 4. The compression device according to claim 3,wherein the expandable portion of the strap comprises two layers, anouter layer of material and an inner layer of material, each saidmaterial having elasticity in at least the transverse direction, theproduct of the modulus of elasticity of the inner-layer-material timesthe thickness of the inner-layer-material being less than the product ofthe modulus of elasticity of the outer-layer-material times thethickness of the outer-layer-material, wherein outer-layer-material issaid loop material and wherein the inner layer of material is affixed tothe outer layer of material, so as to provide a loop ofouter-layer-material above the inner layer when the expandable strapportion is in the non-expanded state, which, in use under the provisionof tension and accordingly expansion of expandable portion of the strapin the transverse direction, can flatten.
 5. The compression deviceaccording to claim 2, wherein the first lateral edge region of thesleeve is trimmable.
 6. The compression device according to claim 1,wherein said main material has a difference quotient of tension intransverse direction from 15% elongation to 20% elongation that is equalto or less than 70% of the difference quotient tension in transversedirection from 20% elongation to 25% elongation; in particular equal toor less than 55% of the difference quotient tension in transversedirection from 20% elongation to 25% elongation, more particularly equalto or less than 45% of the difference quotient tension in transversedirection from 20% elongation to 25% elongation; most particularly equalto or less than 35% of the difference quotient tension in transversedirection from 20% elongation to 25% elongation.
 7. The compressiondevice according to claim 1, wherein said main material has a recoveredelongation in transverse direction equal to or greater than 80%.
 8. Thecompression device according to claim 1, wherein said main material hasan elongation rise in transverse direction equal to or less than 3.5%.9. The compression device according to claim 1, wherein said mainmaterial has at least one of a tension in transverse direction at 30%elongation equal to or greater than 10 N per cm width, and a tension intransverse direction at 30% elongation, after a one minute hold equal toor greater than 10 N per cm width.
 10. The compression device accordingto claim 1, wherein said main material comprises a fibrous fabric. 11.The compression device according to claim 1, wherein the sleeve andclosure system are configured and arranged such that in use, uponclosure of the closure system, the two lateral edges of the sleeve aredrawn towards one another, but do not overlap.
 12. The compressiondevice according to claim 1, wherein the closure system comprises amechanical fastening closure system, and, wherein the first lateral sideregion and/or the second lateral side region are provided with aplurality of tabs, wherein each tab comprises a proximal end portion anda distal end portion, said proximal end portion being releasably orfixedly attached to the first lateral side region and/or second lateralside region of the sleeve, respectively, such that the tab extendsacross the first lateral side edge and/or the second lateral side edge,respectively, in substantially the transverse direction of the sleeve,with the distal end portion positioned away from the central portion ofthe sleeve, wherein each tab has a inner major surface, said inner majorsurface at the distal end portion of the tab comprises one part of amechanical fastening system, and wherein at least the outer surface atthe second lateral side region and/or the first lateral side region,respectively, opposite to each tab comprises the complementary part ofthe mechanical fastening system.
 13. The compression device according toclaim 1, wherein the sleeve includes an elongate, expandable gussetextending substantially lengthwise between the upper and lower edges ofthe sleeve, said gusset being expandable in at least the transversedirection of the sleeve, wherein said expandable gusset comprises amaterial having elasticity in at least the transverse direction and isconfigured and arranged, such that when the expandable gusset is in anon-expanded state there is exteriorly a loop of material risingoutwardly, and when, in use under the provision of tension in thetransverse direction of the sleeve, the expandable gusset expands in thetransverse direction and the loop flattens.